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