Browse Drug Recalls

777 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 777 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 777 FDA drug recalls in 2025.

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DateProductReasonClassFirm
Dec 31, 2025 CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per ... Out of specification for dissolution. Class II AvKARE
Dec 31, 2025 Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only,... Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets ... Class II Alvogen, Inc
Dec 31, 2025 Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drop... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye D... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manu... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
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 Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, R... Failed Impurities/Degradation Specifications: Out of specification result was obtained for the kn... Class III SUN PHARMACEUTICAL INDUSTRIES 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 parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net ... Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and ex... Class III Haleon US Holdings LLC
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 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 22, 2025 Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: D... Failed PH Specifications Class III Cipla USA, Inc.
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 19, 2025 traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufact... Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on ... Class III Zydus Pharmaceuticals (USA) 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

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.