Browse Drug Recalls

3,430 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,430 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 3,430 FDA drug recalls.

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DateProductReasonClassFirm
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
Dec 22, 2025 Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. ... CGMP Deviations: product found to contain lead. Class I HANDELNINE GLOBAL LLC
Dec 8, 2025 ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, S... cGMP Deviations Class II Signature Formulations, LLC
Dec 8, 2025 ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, ... cGMP Deviations Class II Signature Formulations, LLC
Nov 24, 2025 Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Onl... CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Class II Breckenridge Pharmaceutical, Inc.
Nov 24, 2025 Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Onl... CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Class II Breckenridge Pharmaceutical, Inc.
Nov 14, 2025 Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manu... CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... Class II Cipla USA, Inc.
Nov 14, 2025 Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manu... CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... Class II Cipla USA, Inc.
Nov 14, 2025 Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manu... CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... Class II Cipla USA, Inc.
Oct 31, 2025 WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Co... cGMP deviations Class II Blossom Pharmaceuticals
Oct 31, 2025 Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for:... cGMP deviations Class II Blossom Pharmaceuticals
Oct 31, 2025 Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Di... cGMP deviations Class II Blossom Pharmaceuticals
Oct 31, 2025 Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals,... cGMP deviations Class II Blossom Pharmaceuticals
Oct 31, 2025 Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation... cGMP deviations Class II Blossom Pharmaceuticals
Oct 31, 2025 Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Tri... cGMP deviations Class II Blossom Pharmaceuticals
Oct 31, 2025 Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Niv... cGMP deviations Class II Blossom Pharmaceuticals
Oct 31, 2025 Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Gle... cGMP deviations Class II Blossom Pharmaceuticals
Oct 31, 2025 Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporatio... cGMP deviations Class II Blossom Pharmaceuticals
Oct 31, 2025 Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dyn... cGMP deviations Class II Blossom Pharmaceuticals
Oct 31, 2025 Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnar... cGMP deviations Class II Blossom Pharmaceuticals
Oct 31, 2025 Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protect... cGMP deviations Class II Blossom Pharmaceuticals
Oct 31, 2025 Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (5... cGMP deviations Class II Blossom Pharmaceuticals
Oct 22, 2025 clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bot... cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie... Class II Zydus Pharmaceuticals (USA) Inc
Oct 22, 2025 clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bot... cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie... Class II Zydus Pharmaceuticals (USA) Inc
Oct 22, 2025 clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bot... cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie... Class II Zydus Pharmaceuticals (USA) Inc
Oct 14, 2025 Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY,... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSE... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FO... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, ... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUB... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSER... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERIL... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, Fa... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STER... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC

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.