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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.