| January 28, 2026 | Gerber Product Arrowroot Biscuits | New | FDA reports that Gerber Products Company announces a voluntary recall of limited batches of Arrowroot Biscuits out of an abundance of caution due to potential presence of foreign material following supplier recall
Human Foods
| Human Foods |
| December 29, 2025 | Dexcom G6 and G6 Pro software | New | FDA reports that Dexcom issues correction for Dexcom G6 and G6 Pro software
| Medical Devices |
| December 10, 2025 | ByHeart Whole Nutrition infant formula products | Update | FDA reports that the outbreak investigation of infant botulism is ongoing. Do not use ByHeart Whole Nutrition infant formula | Infant Formula |
| December 10, 2025 | Certain ground cinnamon products | Update | FDA reports that more ground cinnamon products added to FDA public health alert due to presence of elevated levels of lead | Human Foods |
| December 2, 2025 | Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors | New | FDA reports that Abbott Diabetes Care has sent all affected customers a letter regarding an issue with certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors providing incorrect low glucose readings
| Medical Devices |
| October 31, 2025 | Unapproved fluoride drug products | New | FDA acts to protect children from unapproved fluoride drug products
| Drugs |
| September 23, 2025 | Sprouts Organics sweet potato apple and spinach, 3.5-ounce pouch | Update | FDA reports that Sprout Organics is expanding the voluntary recall of sweet potato apple and spinach to include additional lot codes | Human Foods |
| September 16, 2025 | Unauthorized infant devices for monitioring vital signs | New | FDA warns consurmers, caregivers, and health care providers not to use unathorized infant devices for monitoring vital signs | Medical Devices |
| September 15, 2025 | Certain t-slim X2 insulin pumps | New | FDA reports that Tandem Diabetes Care issued a correction for certain t:slim X2 insulin pumps due to risk for faulty speaker wiring that may cause malfunction and stop insulin delivery | Medical Devices |
| September 12, 2025 | Dexcom G77 apps and ONE+ apps | Update | FDA reports that Dexcom, Inc. issued a correction for G7 apps and ONE+ apps due to a software design error that does not alert users of unexpected sensor failure | Medical Devices |
| September 2, 2025 | Nicotine pouches | New | FDA urges nicotine pouch manufacturers to use child-resistant packaging following increasing reports of accidental exposure | Tobacco Products |
| August 29, 2025 | Coaxial breath circuit set | New | FDA reports that Hamilton Medical, Inc. has recalled certain lots of the coaxial breathing circuit sets due to possible inner blue tube cracks that may impact ventilation | Medical Devices |
| August 28, 2025 | 4-N-1, DermaCerin, DermaFungal, DermaKleen, DermaMed, DermaSarra, Gel Rite, Hand E Foam, KleenFoam, Lantiseptic, PeriGiene, PeriGuard, Renew Dimethicone, Renew Periprotect, Renew Skin Repair, Ultrasure | New | FDA reports that DermaRite Industries has expanded a voluntary nationwide recall due to potential Burkholderia cepacia contamination
| Drugs |
| August 28, 2025 | HAMILTON-C6 ventilators | New | FDA reports that Hamilton Medical AG has issued a correction for HAMILTON-C6 ventilators due to risk of ventilation interruption from defective circuit board | Medical Devices |
| August 25, 2025 | Hyperbaric oxygen therapy devices | New | FDA reminds health care providers to follow instructions for safe use of hyperbaric oxygen therapy devices - Letter to Health Care Providers | Medical Devices |
| August 12, 2025 | t:slim X2 insulin pumps | New | FDA reports that Tandem Diabetes Care has issued a voluntary medical device correction for select t:slim X2 insulin pumps | Medical Devices |
| July 9, 2025 | AirLife/Vyaire infant heated wire circuits | New | FDA reports an infant breathing system recall: AirLife/Vyaire removes infant heated wire circuits due to risk for inadvertent adapter disconnection during ventilation | Medical Devices |
| June 30, 2025 | Extended-release stimulants for ADHD | New | FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD | Drugs |
| June 25, 2025 | Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer Inc. and Spikevax (COVID-19 Vaccine, mRNA) | New | FDA approves required updated warning in labeling of mRNA COVID-19 vaccines regarding myocarditis and pericarditis following vaccination | Vaccines |
| June 24, 2025 | ELEVIDYS (delandistrogene moxeparvovec-rokl) | New | FDA investigates deaths due to acute liver failure in non-ambulatory Duchenne Muscular Dystrophy patients following ELEVIDYS | Biologics |
| June 18, 2025 | Transderm Scōp (scopolamine transdermal system) | New | FDA adds warning about serious risk of heat-related complications with antinausea patch Transderm Scōp (scopolamine transdermal system) | Drugs |
| June 17, 2025 | Medline Neonatal and Pediatric Convenience Kits containing Smiths Medical ORAL/NASAL endotracheal tubes | New | FDA reports that Medline Industries, LP, has issued a Convenience Kit recall for removing Medline Neonatal and Pediatric Kits containing Smiths Medical ORAL/NASAL endotracheal tubes due to smaller than expected tube diameter that may cause underventilation | Medical Devices |
| June 11, 2025 | Select Newport™ HT70 and Newport™ HT70 Plus ventilators and certain related Newport™ service parts | New | FDA reports that Medtronic has announced a voluntary recall of select Newport™ HT70 and Newport™ HT70 Plus ventilators and certain related Newport™ service parts | Medical Devices |
| 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 |
| June 4, 2025 | Nitrous oxide products | Update | FDA advises consumers not to inhale nitrous oxide products | Human Foods |
| 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 |
