Browse Drug Recalls

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 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 17,874 FDA drug recalls.

DateProductReasonClassFirm
Dec 11, 2023 NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only... Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. Class II Fagron, Inc
Dec 11, 2023 Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Ma... CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product. Class II Legacy Pharmaceutical Packaging LLC
Dec 11, 2023 NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx O... Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. Class II Fagron, Inc
Dec 11, 2023 NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx O... Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. Class II Fagron, Inc
Dec 11, 2023 NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Onl... Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. Class II Fagron, Inc
Dec 8, 2023 Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufa... Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylid... Class III Azurity Pharmaceuticals, Inc.
Dec 4, 2023 Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distribute... Failed Impurities/Degradation Specifications Class II SUN PHARMACEUTICAL INDUSTRIES INC
Nov 29, 2023 Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed... Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutic... Class I Meta Herbal
Nov 29, 2023 ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Inje... STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag con... Class II STAQ Pharma, Inc.
Nov 22, 2023 ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL... Lack of assurance of sterility. Class II Wells Pharma of Houston LLC
Nov 22, 2023 buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets... Failed Dissolution Specifications Class III SUN PHARMACEUTICAL INDUSTRIES INC
Nov 22, 2023 TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET... Chemical Contamination; presence of benzene. Class I Insight Pharmaceuticals Corporation
Nov 22, 2023 B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxin... Presence of Particulate Matter. Class II AnazaoHealth Corporation
Nov 22, 2023 SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL b... Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals Class I Novartis Pharmaceuticals Corporation
Nov 22, 2023 Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber... Presence of Particulate Matter. Class II AnazaoHealth Corporation
Nov 22, 2023 Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for... Failed Dissolution Specifications Class II Lupin Pharmaceuticals Inc.
Nov 20, 2023 Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured ... Failed Dissolution Specifications Class III Siegfried Barbera, SL
Nov 17, 2023 Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx O... Defective Container: powder may leak out of the pouch Class I InvaGen Pharmaceuticals, Inc.
Nov 14, 2023 Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manu... Failed pH Specifications Class II Baxter Healthcare Corporation
Nov 13, 2023 EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% a... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packag... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL ... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glyco... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL ... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral ... Failed Impurities/Degradation Specifications Class II KINDER FARMS LLC
Nov 13, 2023 Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), pa... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) pack... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) e... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Sus... Failed Impurities/Degradation Specifications Class II KINDER FARMS LLC
Nov 13, 2023 Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL O... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) ... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ ... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged ... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Te... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydro... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%),... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Prop... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, T... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), pa... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 10, 2023 PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-73... Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... Class II Golden State Medical Supply Inc.
Nov 10, 2023 Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25... Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL ... Class III Fagron Compounding Services
Nov 10, 2023 PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-73... Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... Class II Golden State Medical Supply Inc.
Nov 10, 2023 Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose pack... OOS for viscosity Class III Teva Pharmaceuticals USA, Inc
Nov 10, 2023 PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-... Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... Class II Golden State Medical Supply Inc.
Nov 9, 2023 Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag,... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, 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.