| September 19, 2024 | Dynacare Baby Powder | FDA reports that Dynarex Corporation is recalling Dynacare Baby Powder, Batch Number B 051 due to possible health risk |
| September 5, 2024 | FreeStyle Libre® 3 sensors | FDA reports continuous glucose monitoring (CGM) sensor recall: Abbott Diabetes Care Inc issues recall for certain FreeStyle Libre 3 sensors due to risk for inaccurate high glucose readings |
| September 4, 2024 | Bivona® Tracheostomy Tubes | FDA reports that Smiths Medical issues urgent medical device notification informing customers of a potential issue with certain Bivona® Tracheostomy Tubes |
| August 28, 2024 | Version 2.7 of the Apple iOS t:connect Mobile App used in conjunction with t:slim X2 Insulin Pump with Control-IQ Technology | FDA reports that Tandem Diabetes Care, Inc. is recalling version 2.7 of the Apple iOS t:connect mobile app used in conjunction with t:slim X2 Insulin Pump with Control-IQ Technology prompted by a software problem leading to pump battery depletion |
| August 15, 2024 | Apple cinnamon fruit puree pouches | FDA issues warning letter to Austrofood and continues robust activities to ensure safety of cinnamon products sold in U.S. |
| August 12, 2024 | Tandem Diabetes Care Inc. t:connect mobile app for iOS devices | FDA reports that Tandem Diabetes Care is providing an update on March 2024 nationwide recall of t:connect mobile app for iOS devices |
| August 9, 2024 | Vivo 45 LS Ventilator | FDA reports that Breas Medical is issuing a voluntary U.S. nationwide urgent medical device correction of Vivo 45 LS Ventilator |
| August 8, 2024 | CVS Health, H-E-B Baby infant formula | FDA reports that Perrigo is issuing a voluntary recall of one batch of premium infant formula with iron milk-based powder due to elevated levels of Vitamin D |
| August 1, 2024 | Geek Bar, Lost Mary, and Bang | FDA warns online retailers selling unauthorized youth appealing e-cigarettes |
| July 31, 2024 | FreeStyle Libre® 3 sensors | FDA reports that Abbott is issuing a voluntary medical device correction for a small number of FreeStyle Libre® 3 sensors in the U.S. |
| July 31, 2024 | MEGA SOFT™, MEGA SOFT DUAL™ and MEGA 2000™ Patient Return Electrodes | FDA raises awareness about safe use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes - Letter to Health Care Providers |
| July 22, 2024 | Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) 100 mL | FDA reports that Hikma Pharmaceuticals USA Inc. is extending the voluntary nationwide recall of one lot of acetaminophen injection, 1000mg/100mL, (10mg/mL) bags due to an individual unit of acetaminophen overwrap found to have contained a labelled bag of dexmedetomidine HCL injection (400mcg/100mL) |
| July 11, 2024 | MEGA SOFT™, MEGA SOFT DUAL™ and MEGA 2000™ Patient Return Electrodes | FDA reports electrode pad correction: Megadyne issues correction for MEGA SOFT, MEGA SOFT DUAL and MEGA 2000 Patient Return Electrodes to limit risk of pediatric burns |
| June 13, 2024 | MEGADYNE MEGA SOFT™ Pediatric Patient Return Electrodes | FDA reports electrode pad recall: Megadyne removes MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes for risk of serious burn injuries to patients |
| June 4, 2024 | Crecelac Infant 0-12 Infant Formula (Lot # 24 039 1 CHE 352-1) | FDA reports that Dairy Manufacturers Inc. is notifying consumers about a safety concern with Crecelac Infant 0-12 Infant Formula (Lot # 24 039 1 CHE 352-1) that is part of an ongoing recall – Expansion of Previous Recall |
| May 25, 2024 | All lot codes for Crecelac Infant 0-12, Farmalac 0-12 and Farmalac 0-12 Low lactose to the retail and wholesale level. | FDA reports that Dairy Manufacturers Inc. is issuing a voluntary recall of products due to non-compliance with requirements under the 21 CFR 106.110 New Infant Formula Registration |
| May 13, 2024 | Cue Health COVID-19 tests | FDA warns home test users, caregivers, and health care providers not to use Cue Health’s COVID-19 tests due to risk of false results |
| May 10, 2024 | Healthwest Minerals Inc. DBA Mt Capra Products Goat Milk Formula Recipe Kit | FDA reports that Healthwest Minerals Inc. DBA Mt Capra Products is recalling Goat Milk Formula Recipe Kit and warns consumers against the use of product as infant formula |
| May 10, 2024 | MEGA SOFT™ pediatric patient return electrode | FDA reports that MEGADYNE™ is initiating global discontinuation and voluntary recall of MEGA SOFT™ pediatric patient return electrode |
| April 18, 2024 | Sammy’s Milk Goat Milk Toddler Formula | FDA asks Sammy’s Milk to provide a warning against the use of Goat Milk Toddler Formula as infant formula |
| February 29, 2024 | Mega Soft Universal and Universal Plus patient return electrodes | FDA reports that Megadyne is reiterating the intended use population change for Megadyne Mega Soft Universal and Universal Plus patient return electrodes |
| February 29, 2024 | Care Plus, Care Plus models 1000-4000 and Lullaby incubators | FDA reports that Wipro GE Healthcare Private Ltd. is recalling Care Plus, Care Plus models 1000-4000 and Lullaby incubators due to problems with door latch |
| February 19, 2024 | Nordic Naturals Baby’s Vitamin D3 Liquid, | FDA reports that Nordic Naturals has issued a voluntary recall of Baby's Vitamin D3 Liquid due to elevated levels of vitamin D3 |
| January 9, 2024 | GE HealthCare EVair and EVair03 Compressors with Certain Ventilators | FDA alerts health care providers about potential exposure to certain chemicals with use of GE HealthCare EVair and EVair03 Compressors with certain ventilators – Letter to Health Care Providers |
| January 8, 2024 | Mega Soft Universal Patient Return Electrode | FDA reports that Megadyne Medical Products, Inc. has recalled Mega Soft Universal Patient Return Electrode due to reports of patient burns |
| January 5, 2024 | Recalled WanaBana apple cinnamon fruit puree pouches- including three packs, Recalled Schnucks-brand cinnamon-flavored applesauce pouches and variety pack, Recalled Weis-brand cinnamon applesauce pouches | FDA reports that recalled cinnamon apple puree and applesauce products containing lead test positive for chromium |
| January 3, 2024 | Neonatal incubators | FDA updates healthcare providers about its ongoing evaluation of airborne chemicals from neonatal incubators - Letter to Health Care Providers |
| December 31, 2023 | Select batches of Nutramigen hypoallergenic infant formula powder | FDA reports that Reckitt/Mead Johnson Nutrition has voluntarily recalled select batches of Nutramigen hypoallergenic infant formula powder because of possible health risk |
| December 14, 2023 | Levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan) | FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan) |
| November 28, 2023 | BCMA-directed or CD-19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies | FDA is investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies |
| November 3, 2023 | WanaBana Apple Cinnamon Fruit Puree Pouches | FDA advises parents and caregivers not to buy or feed WanaBana Apple Cinnamon Fruit Puree Pouches to toddlers and young children because of elevated lead levels |
| November 1, 2023 | Moderna COVID-19 vaccine (2023-2024 Formula) | FDA advises health care providers about the correct dosage and administration of Moderna COVID-19 Vaccine (2023-2024 Formula) for individuals 6 months through 11 years of age |
| October 26, 2023 | Probiotics | FDA raises concerns about probiotic products sold for use in hospitalized preterm infants.
- September 29, 2023: Dear Healthcare Provider Letter |
| October 16, 2023 | Neonatal incubators | FDA provides an update about the evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers- UPDATE October 16, 2023 |
| September 14, 2023 | LittleOak infant formula | FDA alerts parents and caregivers to concerns regarding LittleOak Infant Formula |
September 13, 2023 | TheraBreath Strawberry Splash for Kids 16oz | FDA reports that Church & Dwight issues voluntary nationwide recall of one specific lot of TheraBreath Strawberry Splash for Kids 16oz sold exclusively on Amazon Between May 31 and September 02, 2023, due to microbial contamination identified as yeast (candida parapsilosis) |
| September 29, 2023 | Certain O&M Halyard surgical N95 respirators, surgical masks, and pediatric face masks | FDA provides an update on recommendations for certain O&M Halyard surgical N95 respirators, surgical masks, and pediatric face mask |
| August 1, 2023 | GoHealthy probiotics for infants, toddlers and kids in 2-ounce bottles and GoHealthy probiotics for infants, kids, men and women in 4-ounce bottles | FDA reports that Ozona Organics issues voluntary recall of select liquid probiotic products due to possible health risk |
| July 13, 2023 | NOxBOXi Nitric Oxide System | FDA reports that NOxBOX Ltd. is recalling NOxBOXi Nitric Oxide System for manifold failure that may cause gas leaks and interrupt therapy to neonates |
| July 7, 2023 | Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) | FDA reports that Cipla issues voluntary nationwide recall of six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) due to container defect |
| June 22, 2023 | Elf Bars and Esco Bars e-cigarettes | FDA inspection blitz leads to more than 180 warning letters to retailers for the illegal sale of youth-appealing Elf Bar and Esco Bars e-cigarettes |
| June 13, 2023 | Neonatal incubators | FDA provides an update about the ongoing evaluation of airborne chemicals from neonatal incubators – Letter to Health Care Providers |
| May 11, 2023 | Prescription stimulant medications | FDA updates warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions |
| April 13, 2023 | Opioid pain medicines | FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use |
| April 12, 2023 | Abbott FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash glucose monitoring system readers | FDA reports that Abbott has recalled the readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash glucose monitoring systems for risk of extreme heat and fire |
| Issued April 12, 2023; Updated April 21, 2023 | Certain O&M Halyard surgical N95 respirators, surgical masks, and pediatric face masks | FDA reports a risk of protection failure with certain O&M Halyard surgical N95 respirators, surgical masks, and pediatric face masks |
| March 17, 2023 | Gerber® Good Start® SootheProTM Powdered Infant Formula | FDA reports that Perrigo announces voluntary recall of limited quantity of Gerber® Good Start® SootheProTM powdered infant formula |
| March 3, 2023 | All allergenic extracts for diagnosis of food allergy | FDA requires warning about anaphylaxis following false negative food allergen skin test results in the prescribing information for all allergenic extracts for diagnosis of food allergy |
| February 23, 2023 | Neonatal incubators | FDA informs health care providers and facilities about the potential for exposure to airborne chemicals that may be released from neonatal incubators- Letter to Health Care Providers |
| February 20, 2023 | Prosobee 12.9 oz Simply Plant Based Infant Formula | FDA reports that Reckitt is recalling two batches of Prosobee 12.9 oz Simply Plant Based Infant Formula because of possible health risk |
| February 9, 2023 | Hospira's unapproved Potassium Phosphates drug product | FDA warns that infants may be at risk for aluminum toxicity when using unapproved potassium phosphates drug product |
| January 30, 2023 | Banana Boat Hair & Scalp Sunscreen | FDA reports that Edgewell Personal Care has issued a voluntary nationwide recall of Banana Boat Hair & Scalp Sunscreen due to the presence of benzene UPDATED |
| November 3, 2022 | Infant Head Shaping Pillows | FDA recommends not to use infant head shaping pillows to prevent or treat any medical condition |
| September 6, 2022 | Mother’s Touch formula | FDA advises parents and caregivers not to buy or give Mother’s Touch formula to infants |
| August 18, 2022 | VPR Brands LP (“Krave Nic”) flavored nicotine gummies | FDA warns manufacturer for marketing illegal flavored nicotine gummies |
| August 16, 2022 | Capri Sun wild cherry flavored juice drink blend | FDA reports that Kraft Heinz is announcing a voluntary recall of Capri Sun Wild Cherry flavored juice drink blend beverages due to potential for chemical contaminants |
| August 11, 2022 | At-Home COVID-19 antigen tests | FDA advises steps to take reduce your risk of false negative At-Home COVID-19 antigen tests |
| August 04, 2022 | Major Pharmaceuticals Milk of Magnesia oral suspension | FDA reports that Plastikon Healthcare expands voluntary nationwide recall of Milk of Magnesia oral suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone oral suspension due to microbial contamination |
| July 29, 2022 | Banana Boat Hair & Scalp sunscreen | FDA reports that Edgewell Personal Care issued a voluntary nationwide recall of Banana Boat Hair & Scalp Sunscreen due to the presence of benzene |
| July 1, 2022 | Plug Heist Trap House homemade infant formula | FDA issues an alert on homemade infant formula from Plug Heist Trap House EST. 2017 |
| June 28, 2022 | Baby neck floats | FDA warns to not use baby neck floats due to the risk of death or injury |
| April 19, 2022 | Genetic non-invasive prenatal screening (NIPS) tests | FDA warns that genetic non-invasive prenatal screening tests may have incorrect results |
| April 12, 2022 | Insulin Glargine (Insulin glargine-yfgn) injection | FDA reports that Mylan Pharmaceuticals Inc., a Viatris Company, conducting voluntary nationwide recall of one batch of Insulin Glargine (Insulin glargine-yfgn) injection, 100 units/mL (U-100), due to the potential for a missing label in the batch |
| March 30, 2022 | Contrast Media “Dye,” used for X-rays and other medical imaging procedures | FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging |
| March 24, 2022 | Major Pharmaceutical’s Milk of Magnesia oral suspension 2400 mg/30 mL | FDA reports that Plastikon Healthcare issues voluntary nationwide recall of Milk of Magnesia oral suspension 2400 mg/30 mL, Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, and Acetaminophen 650mg/ 20.3mL, Unit Dose Cups, due to microbial contamination |
| March 21, 2022 | SYMJEPI® (Epinephrine) Injection | FDA reports that Adamis Pharmaceuticals Corporation issues nationwide voluntary recall of SYMJEPI® (Epinephrine) Injection for potential manufacturing defect |
| March 18, 2022 | At-home COVID-19 tests | FDA alerts people to use and store at-home COVID-19 tests properly to avoid potential harm |
| February 17, 2022 | Certain powdered infant formula produced in Abbott Nutrition’s Facility in Sturgis, Michigan | FDA warns consumers not to use certain powdered infant formula produced in Abbott Nutrition’s facility in Sturgis, Michigan |
| February 8, 2022 | Enteral feeding delivery sets | FDA warns of potential risk of strangulation in children who use enteral feeding delivery sets |
| December 23, 2021 | Healthy Beauty Angel Formula | FDA issues an alert on “Healthy Beauty” Angel Formula intended for infants and children by Moor Herbs |
| November 2, 2021 | Alcohol-based hand sanitizers | FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury |
| October 8, 2021 | Specific lots of Parent’s Choice rice baby cereal | FDA reports that Maple Island Inc. issued a voluntary recall of three lots of Parent’s Choice rice baby cereal |
| October 5, 2021 | Ellume COVID-19 Home Tests | FDA reports the potential for false positive results with certain lots of Ellume COVID-19 Home Tests due to a manufacturing issue |
| September 1, 2021 | Xeljanz and Xeljanz XR (tofacitinib) | FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions |
| July 15, 2021 | NuVasive MAGEC System Implants | FDA reports potential concerns with NuVasive MAGEC System Implants |
| July 14, 2021 | Specific NEUTROGENA® and AVEENO® aerosol sunscreen products | FDA reports that Johnson & Johnson Consumer Inc. issued a voluntary recall of specific NEUTROGENA® and AVEENO® aerosol sunscreen products due to the presence of benzene |
| July 7, 2021 | Hydroxyethyl starch (HES) products | FDA requires labeling changes on mortality, kidney injury, and excess bleeding with hydroxyethyl starch products |
| June 16, 2021 | Alcohol-based hand sanitizers | FDA warns that vapors from alcohol-based hand sanitizers can have side effects |
| June 14, 2021 | Designed By Nature goat’s milk, cow’s milk and base milk formulas | FDA reports that Designed By Nature voluntarily recalls goat’s milk, cow’s milk and base milk formulas due to possible health risk |
| March 31, 2021 | Lamotrigine (Lamictal) | An FDA review of studies shows a potential increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease |
| March 25, 2021 | Propylhexedrine | FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious harm |
| February 24, 2021 | Homemade infant formula | FDA advises parents and caregivers to not make or feed homemade infant formula to infants |
| February 12, 2021 | Pulse oximeters | FDA informs patients and health care providers about pulse oximeter accuracy and limitations |
| February 9, 2021 | COVID-19 vaccines | FDA monitors COVID-19 vaccine safety |
| January 4, 2021 | Curative SARS-Cov-2 test | FDA warns of the risk of false results with the Curative SARS-Cov-2 test for COVID-19 |
| October 28, 2020 | Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products | FDA reports that Sunstar Americas, Inc. is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products due to possible contamination with the bacteria Burkholderia lata |
| September 24, 2020 | Diphenhydramine (Benadryl) | FDA warns about serious problems with higher than recommended doses of the allergy medicine diphenhydramine (Benadryl) |
| September 24, 2020 | Dental amalgam | FDA provides recommendations about the use of dental amalgam in certain high-risk populations |
| September 23, 2020 | Metformin hydrochloride (Riomet ER) | FDA reports that Sun Pharmaceutical Industries, Inc. is issuing a voluntary nationwide recall of RIOMET ER™ (Metformin Hydrochloride for Extended-Release Oral Suspension) due to N-nitrosodimethylamine content above the acceptable daily intake limit |
| September 23, 2020 | Benzodiazepines | FDA requires Boxed Warning updated to improve safe use of benzodiazepine drug class |
| August 27, 2020 | Hand sanitizers | FDA updates on hand sanitizers consumers should not use |
| July 23, 2020 | Naloxone | FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder |
| July 2, 2020 | Hand sanitizers contaminated with methanol | FDA warns consumers of risk of methanol contamination in certain hand sanitizers |
| June 19, 2020 | Hand sanitizers contaminated with methanol | FDA advises consumers not to use any hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, due to the potential presence of methanol (wood alcohol) |
| March 10, 2020 | HiRes Ultra and Ultra 30 cochlear implant devices | FDA reports that Advanced Bionics will voluntarily initiate a field corrective action related to the initial version of HiRes Ultra and Ultra 30 cochlear implant devices due to a decrease in performance experienced by a small percentage of recipients |
| March 4, 2020 | Montelukast (Singulair) | FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis |
| February 27, 2020 | Ozone and ultraviolet (UV) light products for cleaning continuous positive airway pressure (CPAP) devices and accessories | FDA reports potential risks associated with the use of unauthorized ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories (no ozone/UV cleaning products are currently approved) |
| December 19, 2019 | Gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) | FDA warns about serious breathing problems for patients with respiratory risk factors taking seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) |
| November 5, 2019 | Biotin | FDA warns that biotin may interfere with lab tests: update to 2017 Safety Communication |
| August 30, 2019 | E-cigarette products | FDA warns of incidents of severe respiratory disease associated with use of an e-cigarette product |
| August 28, 2019 | Mavyret, Zepatier, Vosevi | FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease |
| June 27, 2019 | Certain Medtronic MiniMed™ insulin pumps | FDA warns about potential cybersecurity vulnerabilities affecting certain Medtronic MiniMed insulin pumps |
| June 7, 2019 | Flavored e-liquid products | FDA, FTC take action to protect kids by citing four firms that make, sell flavored e-liquids for violations related to online posts by social media influencers on their behalf |
| June 7, 2019 | Bobbie Baby Inc. infant formula | FDA advises consumers to stop using infant formula from Bobbie Baby Inc |
| May 17, 2019 | Continuous glucose monitoring systems (CGMs), insulin pumps, or automated insulin dosing (AID) systems | FDA warns people with diabetes and health care providers against the use of devices for diabetes management not authorized for sale in the United States |
| May 7, 2019 | Medtronic pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) | FDA alerts providers and patients to check for premature battery depletion in certain Medtronic pacemakers |
| April 10, 2019 | Medical devices for concussion diagnosis, treatment, or management without FDA approval or clearance | FDA recommends only using cleared or approved medical devices to help assess or diagnose a head injury, including concussion |
| April 9, 2019 | Opioid pain medicines | FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering |
| April 8, 2019 | Previously owned test strips | FDA warns against use of previously owned test strips or test strips not authorized for sale in the United States |
| March 21, 2019 | Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors | FDA warns about cybersecurity vulnerabilities affecting Medtronic implantable cardiac devices, programmers, and home monitors |
| March 20, 2019 | DG™/health NATURALS baby Cough Syrup + Mucus | FDA posts Kingston Pharma, LLC recall of " DG™/health NATURALS baby Cough Syrup + Mucus” as a public service because of possible health risk |
| March 6, 2019 | Zoll LifeVest 4000 Wearable Cardioverter Defibrillator | FDA updates warning on Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - software update for potential lack of treatment (shock) delivery due to device failure |
| December 20, 2018 | Teething jewelry (includes necklaces, bracelets and other jewelry) | FDA warns against use of teething necklaces, bracelets, and other jewelry marketed for relieving teething pain or providing sensory stimulation |
| December 20, 2018 | Fluoroquinolone antibiotics | FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients |
| November 20, 2018 | Gilenya (fingolomid) | FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod) |
| November 16, 2018 | Honey pacifiers | FDA reports that honey pacifiers are suspected in Texas infant botulism cases |
| November 15, 2018 | Flavored tobacco products, menthol in cigarettes | FDA Commissioner Scott Gottlieb, M.D., issues a statement on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes |
| November 1, 2018 | Genetic laboratory tests claiming to predict response to specific medications | FDA warns against the use of many genetic tests with unapproved claims to predict patient response to specific medications |
| September 12, 2018 | E-cigarettes | FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access |
| August 3, 2018 | Zithromax, Zmax (azithromycin) | FDA warns about increased risk of cancer relapse with long-term use of azithromycin (Zithromax, Zmax) antibiotic after donor stem cell transplant |
| July 10, 2018 | Fluoroquinolone antibiotics | FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes |
| May 23, 2018 | Over-the-counter (OTC) oral drug products containing benzocaine | FDA warns about oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics because of risk of serious and potentially fatal blood disorder. |
| May 18, 2018 | Products containing dolutegravir (Juluca, Tivicay, Triumeq) | FDA evaluates potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq) |
| Apr. 25, 2018 | Lamictal (lamotrigine) | FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal). |
| February 22, 2018 | Biaxin (clarithromycin) | FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease. |
| January 30, 2018 | Over-the counter (OTC) anti-diarrhea drug loperamide | FDA limits packaging for anti-diarrhea medicine loperamide (Imodium) to encourage safe use. |
| January 11, 2018 | Prescription cough and cold medicines containing codeine or hydrocodone | FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older. |
| December 20, 2017 | Long-acting beta agonists (LABAs) | FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS) |
| December 19, 2017 | Gadolinium-based contrast agents (GBCAs) | FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings |
| May 22, 2017 | Gadolinium-based contrast agents (GBCAs) | FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue
Please refer to the updated Drug Safety Communication for GBCAs dated December 19, 2017 |
| Apr. 27, 2017 | General Anesthetic and Sedation Drugs | FDA approves label changes for use of general anesthetic and sedation drugs in young children |
| Apr. 20, 2017 | Codeine and tramadol containing products | FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women |
| Jan. 27, 2017 | Hyland's belladonna-containing homeopathic teething products | FDA confirms elevated levels of belladonna in certain homeopathic teething products. |
| Dec. 14, 2016 | General anesthetics and sedation drugs | FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women |
| Aug. 31, 2016 | The combination of opioid pain or cough medicines with benzodiazepines | FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning |
| July 26, 2016 | Oral and injectable flouroquinolone antibiotics | FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects |
| June 7, 2016 | Imodium (loperamide) | FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse |
| June 6, 2016 | Over-the-counter antacid products containing aspirin (such as Alka-Seltzer Original, Bromo Seltzer, Medique Medi Seltzer, Picot Plus Effervescent, Vida Mia Pain Relief, Winco Foods Effervescent Antacid and Pain Relief, and Zee-Seltzer Antacid and Pain Reliever) | FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin |
| May 12, 2016 | Flouroquinolone antibiotics | FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together |
| May 10, 2016 | Zyprexa, Zyprexa Zydis, Zyprexa Relprevy, Symbyax (olanzapine) | FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax) |
| May 3, 2016 | Abilify, Abilify Maintena, Aristada (aripprazole) | FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada) |
| April 8, 2016 | Metformin | FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function |
| March 22, 2016 | Opioid pain medicines | FDA warns about several safety issues with opioid pain medicines; requires label changes |
| Jan. 4, 2016 | Noxafil (posaconazole) | FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved |
| Nov. 17, 2015 | Iodine-containing Contrast Agents (Cystografin, MD-76R,Cholografin Meglumine,Visipaque, Omnipaque, Isovue,Ultravist, Conray, Optiray,Hexabrix, Oxilan) | FDA advises of rare cases of underactive thyroid in infants given iodine-containing contrast agents for medical imaging |
| Sept. 21, 2015 | Ultram, Ultram ER, Conzip, and generics (tramadol) | FDA evaluates the risks of using the pain medicine tramadol in children aged 17 and younger |
| July 16, 2015 | Proglycem (diazoxide) | FDA warns about a serious lung condition in infants and newborns treated with Proglycem (diazoxide) |
| July 1, 2015 | Codeine cough and cold medicines | FDA evaluates the potential risks of using codeine cough-and-cold medicines in children |
| June 26, 2014 | Oral viscous lidocaine 2% solution | FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning |
| June 25, 2014 | Over- the-counter acne products (such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean&Clear, and as store brands) | FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products |
| Mar. 31, 2014 | Revatio (sildenafil) | FDA clarifies warning about pediatric use of Revatio (sildenafil) for pulmonary arterial hypertension |
| Dec. 17, 2013 | Concerta (methylphenidate hydrochloride), Daytrana (methylphenidate), Focalin and Focalin XR (dexmethylphenidate hydrochloride), Metadate CD and Metadate ER (methylphenidate hydrochloride), Methylin and Methylin ER (methylphenidate hydrochloride), Quillivant XR (methylphenidate hydrochloride), Ritalin, Ritalin LA, and Ritalin SR (methylphenidate hydrochloride) | FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes. |
| Feb. 26, 2013 | Sensipar (cinacalcet hydrochloride) | FDA suspends clinical studies of Sensipar (cinacalcet hydrochloride) after report of death |
| Feb. 20, 2013 | Codeine and Codeine-Containing Products | FDA updates safety review of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy. |
| Oct. 25, 2012 | Over the-counter tetrahydrozoline, oxymetazoline, or naphazoline containing eye drops and nasal decongestant sprays | FDA reports serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays |
| Aug. 30, 2012 | Revatio (silfenadil) | FDA recommends against use of Revatio (sildenafil) in children with pulmonary hypertension |
| Aug. 15, 2012 | Codeine and Codeine-Containing Products | FDA warns that codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death |
| June 29, 2012 | Zofran (ondansetron) | FDA reports new information regarding QT prolongation with ondansetron (Zofran) |
| Dec. 22, 2011 | Acetaminophen | FDA informs the public of another concentration of liquid acetaminophen marketed for infants |
| Dec. 14, 2011 | Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, Pexeva (paroxetine); Zoloft (sertraline); Viibryd (vilazodone) | FDA reports the potential risk of a rare heart and lung condition in newborn babies associated with the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy |
| Nov. 3, 2011 | Tumor necrosis factor (TNF) blockers [Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab) | FDA provides a safety update Tumor Necrosis Factor (TNF) blockers and the risk for pediatric malignancy |
| Nov. 1, 2011 | Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate), Focalin, Focalin XR (dexmethylphenidate), Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostate (dextroamphetamine sulfate), Vyvanse (lisdexamfetamine dimesylate), Adderall, Adderall XR (amphetamine, mixed salts), Desoxyn (methamphetamine), Cylert- no longer marketed (pemoline), Strattera (atomoxetine) | FDA provides a safety update of medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and young adults |
| Sep. 15, 2011 | Zofran (ondansetron) | FDA reports abnormal heart rhythms may be associated with use of Zofran (ondansetron) |
| Aug. 4, 2011 | Recombinant Human Growth Hormone (somatropin) | FDA provides a safety update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death |
| July 11, 2011 | Tamiflu (oseltamivir phosphate) for Oral Suspension | FDA reports important safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspension |
| June 30, 2011 | Valproate sodium, valproic acid, divalproex sodium | FDA reports that children born to mothers who took Valproate products while pregnant may have impaired cognitive development |
| May 20, 2011 | SimplyThick | FDA warns healthcare professionals and the public not to feed SimplyThick to infants born before 37 weeks gestation because of the risk of necrotizing enterocolitis (NEC) |
| April 15, 2011 | Long-acting beta agonists (LABAs): Symbicort (budesonide and formoterol), Advair Diskus (fluticasone and salmeterol), Dulera (mometasone and formoterol), Foradil, Foradil with fluticasone (formoterol) | FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs) |
| Mar. 8, 2011 | Kaletra (lopinavir/ritonavir) | FDA warns of serious health problems seen in premature babies given Kaletra (lopinavir/ritonavir) oral solution |
| Feb. 22, 2011 | Antipsychotic drugs | FDA updates antipsychotic drug labels on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns |
| Jan. 12, 2011 | Lantus (insulin glargine) | FDA provides an update to an ongoing safety review of Lantus (insulin glargine) and possible risk of cancer |
| Dec. 14, 2010 | Tessalon (benzonatate) | FDA reports a death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age |
| Sep. 15, 2010 | Valcyte (valganciclovir hydrochloride) | FDA provides new dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients |
| Aug. 12, 2010 | Lamictal (lamotrigine) | FDA reports aseptic meningitis associated with use of Lamictal (lamotrigine) |
| July 29, 2010 | Evamist (estradiol transdermal spray) | FDA reports an ongoing safety review of Evamist (estradiol transdermal spray) and unintended Ongoing exposure of children and pets to topical estrogen |
| June 15, 2010 | Vitamin D Supplement Products | FDA reports infant overdose risk with liquid Vitamin D |
| June 2, 2010 | Serevent Diskus (Salmeterol); Foradil Aerolizer (Formoterol); Foradil Certihaler* (Formoterol); Advair Diskus (Salmeterol/Fluticasone); Advair HFA (Salmeterol/Fluticasone); Symbiort (Formoterol/Budesonide); Brovana (Arformoterol); Perforomist (Formoterol) | FDA reports that drug labels now contain updated recommendations on the appropriate use of long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs) |
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