Browse Drug Recalls
14,136 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,136 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 14,136 FDA drug recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 31, 2025 | BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manuf... | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... | Class II | Wizcure Pharmaa Private Limited |
| Dec 30, 2025 | Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by... | Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsule... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Dec 30, 2025 | Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercar... | Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, ... | Class II | Glenmark Pharmaceuticals Inc., USA |
| 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 |
| Dec 22, 2025 | Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Ba... | Presence of particulate matter: plastic particles from the bottle rim were observed floating into... | Class II | Baxter Healthcare Corporation |
| Dec 19, 2025 | INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and ... | Failed Disintegration Specifications: above the time expected. | Class II | Sato Pharmaceutical Co., Ltd |
| Dec 19, 2025 | Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, ... | Presence of Particulate Matter: Hair was found in a prefilled syringe | Class II | Novo Nordisk Inc. |
| Dec 19, 2025 | Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Ma... | Presence of Particulate Matter: Hair was found in a prefilled syringe | Class II | Novo Nordisk Inc. |
| Dec 18, 2025 | Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection... | Presence of particulate matter - Glass like particles. | Class II | Imprimis NJOF, LLC |
| Dec 18, 2025 | Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single... | Presence of particulate matter - Glass like particles. | Class II | Imprimis NJOF, LLC |
| Dec 18, 2025 | Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use... | Presence of particulate matter - Glass like particles. | Class II | Imprimis NJOF, LLC |
| Dec 17, 2025 | BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and I... | Lack of Assurance of Sterlity | Class II | CareFusion 213, LLC |
| Dec 16, 2025 | Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx o... | Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. | Class II | SpecGx, LLC |
| Dec 16, 2025 | Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx onl... | Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. | Class II | SpecGx, LLC |
| Dec 12, 2025 | Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg,... | Presence of particulate matter: potential presence of metal particulates in the product. | Class II | Merck Sharp & Dohme LLC |
| Dec 12, 2025 | Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Onl... | Presence of particulate matter: potential presence of metal particulates in the product. | Class II | Merck Sharp & Dohme LLC |
| Dec 9, 2025 | Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., O... | Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint | Class II | SUN PHARMA /TARO |
| 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 26, 2025 | Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, ... | Presence of Foreign Tablets/Capsules | Class II | Golden State Medical Supply 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 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 20, 2025 | Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Op... | Incorrect Product Formulation | Class II | Fagron Compounding Services |
| Nov 17, 2025 | Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Phar... | Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, ... | Class II | Preferred Pharmaceuticals, 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.