Browse Drug Recalls

3,368 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,368 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 3,368 FDA drug recalls.

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DateProductReasonClassFirm
Feb 13, 2026 Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01... CGMP Deviations This recall has been initiated due to failing to complete process validation and ... Class II Harbin Jixianglong Biotech Co., Ltd.
Feb 13, 2026 Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-0... CGMP Deviations This recall has been initiated due to failing to complete process validation and ... Class II Harbin Jixianglong Biotech Co., Ltd.
Feb 2, 2026 Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4... cGMP deviations Class II Pro Numb Tattoo Numbing Spray LLC
Feb 2, 2026 Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL]... cGMP deviations Class II Pro Numb Tattoo Numbing Spray LLC
Jan 21, 2026 Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100... cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. Class II Unichem Pharmaceuticals USA Inc.
Jan 20, 2026 Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium C... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sa... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, M... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box,... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per c... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towele... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Cu... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 pa... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wi... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme Unit... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette,... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, M... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wi... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.1... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, b... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 p... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 20, 2026 Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelett... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 6, 2026 AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each cGMP deviations. Class II Encon Safety Products Co
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

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.