Browse Drug Recalls

27 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 27 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 27 FDA drug recalls.

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DateProductReasonClassFirm
Dec 26, 2025 Benadryl, 25'S 2PK Box, UPC 815556020316 CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 8155560... CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 DAYQUIL COLD & FLU, 32CT/2PK CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 PEPCID COMPLETE - 25CT CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Bayer 2Pk- 25 CT CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Claritin, 20 Count, UPC: 655708016305 CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 NYQUIL COLD & FLU -32CT/2PK CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 co... CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 PEPTO BISMOL 32CT CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 ind... CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, ... CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) ... CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Toothpaste: a) COLGATE, TOOTHPASTE, WHITENING, 2.5oz, 24ct; UPC: 035000511065... CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 EXCEDRIN 2'S DISP.- 30 CT CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463 CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989 CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 MOTRIN 2'S DISP.- 50CT CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #... CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Aleve 1's, 60 CT CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946;... CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319 CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Swan, White Clear Alcohol, 50%, 16oz, 12 count CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 EXCEDRIN MIGRAINE 2'S- 25 CT CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 LIQUID DAYQUIL 12/8oz CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU ... CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.