June 6, 2025 | Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs | New | FDA reports that Church & Dwight Co., Inc. has issued a voluntary nationwide recall of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs due to microbial contamination | Drugs |
May 16, 2025 | Cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names) | New | FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names) | Drugs |
March 11, 2025 | Limited number of acne products containing benzoyl peroxide | New | FDA alerts the public and industry that a limited number of voluntary recalls have been initiated after FDA testing of acne products for benzene; findings show a small number of products with elevated levels of benzene contamination | Drugs |
February 5, 2025 | Diabetes-related smartphone device alert settings | New | FDA alerts patients to regularly check diabetes-related smartphone device alert settings, especially following phone hardware or software changes | Medical Devices |
January 31, 2025 | Gerber® Soothe N Chew® Teething Sticks | New | FDA reports that Gerber Products Company announces recall and discontinuation of all batches of Gerber® Soothe N Chew® Teething Sticks due to choking hazard | Human Foods |
January 16, 2025 | Neonatal incubators | Update | FDA provides an update: Evaluation of airborne chemicals from neonatal incubators - Letter to Health Care Providers | Medical Devices |
December 5, 2024 | E-cigarettes | New | FDA warns more than 100 retailers for illegal sale of youth appealing e-cigarettes, including Geek Bar | Tobacco Products |
October 30, 2024 | Disposable e-cigarettes with designs and functionalities that resemble smart technology, including phones and gaming devices | New | FDA warns firms illegally selling e-cigarettes resembling products with smart technology, including phones and gaming devices | Tobacco Products |
October 28, 2024 | Dynacare Baby Powder | Update | FDA reports that Dynarex Corporation is expanding a recall to include additional products due to possible health risk | Cosmetics |
October 17, 2024 | Medtronic MiniMed 600 and 700 Series insulin pumps | New | FDA reports an insulin pump recall: Medtronic notifies users of MiniMed 600 and 700 Series pumps of risk of shorter than expected battery life | Medical Devices |
October 15, 2024 | Zyno Medical Z-800, Z-800F, Z-800W, and Z800WF infusion pumps | New | FDA reports an infusion pump recall: Zyno Medical removes Z-800, Z-800F, Z-800W, and Z800WF infusion pumps due to an air-in-line software defect that may allow larger than expected air bubbles to enter patients | Medical Devices |
October 7, 2024 | Happy Moose Juice Tropical Roots and Happy Moose Strawberry Fields | New | FDA reports that Youngstown Grape Distributors Inc. is recalling Happy Moose Juice Tropical Roots and Happy Moose Strawberry Fields because of possible health risk | Human Foods |
October 7, 2024 | Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators | New | FDA reports that Philips Respironics has issued additional usage instructions for Trilogy Evo ventilators related to use of in-line nebulizers | Medical Devices |
September 5, 2024 | FreeStyle Libre® 3 sensors | Update | 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 | Medical Devices |
September 4, 2024 | Bivona® Tracheostomy Tubes | New | FDA reports that Smiths Medical issues urgent medical device notification informing customers of a potential issue with certain Bivona® Tracheostomy Tubes | Medical Devices |
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 | Update | 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 | Medical Devices |
August 15, 2024 | Apple cinnamon fruit puree pouches | New | FDA issues warning letter to Austrofood and continues robust activities to ensure safety of cinnamon products sold in U.S. | Human Foods |
August 9, 2024 | Vivo 45 LS Ventilator | New | FDA reports that Breas Medical is issuing a voluntary U.S. nationwide urgent medical device correction of Vivo 45 LS Ventilator | Medical Devices |
August 8, 2024 | CVS Health, H-E-B Baby infant formula | New | 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 | Infant Formula |
August 1, 2024 | Geek Bar, Lost Mary, and Bang | New | FDA warns online retailers selling unauthorized youth appealing e-cigarettes | Tobacco Products |
July 31, 2024 | MEGA SOFT™, MEGA SOFT DUAL™ and MEGA 2000™ Patient Return Electrodes | Update | FDA raises awareness about safe use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes - Letter to Health Care Providers | Medical Devices |
July 22, 2024 | Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) 100 mL | New | 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) | Drugs |
June 4, 2024 | Crecelac Infant 0-12 Infant Formula (Lot # 24 039 1 CHE 352-1) | Update | 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 | Infant Formula |
October 16, 2024 | Cue Health COVID-19 tests | Update | 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 | Medical Devices |
May 10, 2024 | Healthwest Minerals Inc. DBA Mt Capra Products Goat Milk Formula Recipe Kit | New | 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 | Infant Formula |
April 18, 2024 | Sammy’s Milk Goat Milk Toddler Formula | New | FDA asks Sammy’s Milk to provide a warning against the use of Goat Milk Toddler Formula as infant formula | Infant Formula |
February 29, 2024 | Care Plus, Care Plus models 1000-4000 and Lullaby incubators | New | 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 | Medical Devices |
February 19, 2024 | Nordic Naturals Baby’s Vitamin D3 Liquid, | New | FDA reports that Nordic Naturals has issued a voluntary recall of Baby's Vitamin D3 Liquid due to elevated levels of vitamin D3 | Dietary Supplements |
August 15, 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 | Update | FDA reports that recalled cinnamon apple puree and applesauce products containing lead test positive for chromium | Human Foods |
December 31, 2023 | Select batches of Nutramigen hypoallergenic infant formula powder | New | FDA reports that Reckitt/Mead Johnson Nutrition has voluntarily recalled select batches of Nutramigen hypoallergenic infant formula powder because of possible health risk | Infant Formula |
December 14, 2023 | Levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan) | New | FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan) | Drugs |
November 28, 2023 | BCMA-directed or CD-19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies | New | FDA is investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies | Biologics |
November 1, 2023 | Moderna COVID-19 vaccine (2023-2024 Formula) | New | 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 | Vaccines |
October 26, 2023 | Probiotics | Update | FDA raises concerns about probiotic products sold for use in hospitalized preterm infants. | Dietary Supplements |
September 14, 2023 | LittleOak infant formula | New | FDA alerts parents and caregivers to concerns regarding LittleOak Infant Formula | Infant Formula |
September 13, 2023 | TheraBreath Strawberry Splash for Kids 16oz | New | 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) | Human Foods |
September 29, 2023 | Certain O&M Halyard surgical N95 respirators, surgical masks, and pediatric face masks | Update | FDA provides an update on recommendations for certain O&M Halyard surgical N95 respirators, surgical masks, and pediatric face mask | Medical Devices |
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 | New | FDA reports that Ozona Organics issues voluntary recall of select liquid probiotic products due to possible health risk | Dietary Supplements |
July 13, 2023 | NOxBOXi Nitric Oxide System | New | FDA reports that NOxBOX Ltd. is recalling NOxBOXi Nitric Oxide System for manifold failure that may cause gas leaks and interrupt therapy to neonates | Medical Devices |
July 7, 2023 | Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) | New | 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 | Drugs |
June 22, 2023 | Elf Bars and Esco Bars e-cigarettes | New | 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 | Tobacco Products |