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Browse Drug Recalls

3,368 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,368 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 3,368 FDA drug recalls.

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DateProductReasonClassFirm
Nov 10, 2022 PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 5... CGMP Deviations: Potential for cross contamination due to product carry over. Class II Nephron Sterile Compounding Center LLC
Nov 9, 2022 Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Cont... CGMP deviations Class II DISCOVERY PHARMA LLC
Nov 5, 2022 Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, pack... CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured u... Class II Adam's Polishes LLC
Nov 2, 2022 Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distribut... cGMP deviation: discontinue of stability support for product. Class II Direct Rx
Oct 13, 2022 Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufacture... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, R... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-7... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, U... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Ma... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper ... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tub... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx O... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactur... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manu... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, ... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reli... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment ... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL droppe... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, ... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper b... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufact... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) pe... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufa... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 m... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bo... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dro... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit... CGMP Deviations: Class II Akorn, Inc.
Oct 6, 2022 SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL)... CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. A... Class II Southwest Iowa Renewable Energy LLC
Oct 5, 2022 Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottle... CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Class II Aurobindo Pharma USA Inc.
Sep 30, 2022 Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged ... cGMP Deviations: Out of specification for assay of one of the preservative ingredients. Class II VistaPharm, Inc.
Sep 16, 2022 Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx... CGMP deviations: Out of specification results obtained during routine stability testing for ethan... Class II Novartis Pharmaceuticals Corporation
Sep 12, 2022 Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distrib... CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of ef... Class II Direct Rx
Sep 1, 2022 Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can... CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All I... Class II SUPERIOR GLOVE WORKS, LTD.
Aug 31, 2022 Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufact... cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scop... Class II Akorn, Inc.
Aug 31, 2022 Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) t... cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scop... Class II Akorn, Inc.
Aug 23, 2022 Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distribute... CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ing... Class II Teva Pharmaceuticals USA Inc
Aug 17, 2022 Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By ... CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of ef... Class II Padagis US LLC
Aug 15, 2022 Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99... Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the compone... Class II Ultra Chem Labs Corp
Aug 15, 2022 Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99... Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the compone... Class II Ultra Chem Labs Corp
Aug 10, 2022 Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL... cGMP Deviations: deviations leading to potential cross-contamination. Class II Nephron Sc Inc
Aug 10, 2022 Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Per... cGMP deviation: Product held outside of appropriate temperature storage conditions. Class II Family Dollar Stores, Llc.
Aug 10, 2022 Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mm... CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. Class II Nephron Sterile Compounding Center LLC
Aug 10, 2022 Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 47... cGMP deviation: Product held outside of appropriate temperature storage conditions. Class II Family Dollar Stores, Llc.
Aug 10, 2022 Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevent... cGMP deviation: Product held outside of appropriate temperature storage conditions. Class II Family Dollar Stores, Llc.
Aug 10, 2022 PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Via... CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. Class II Nephron Sterile Compounding Center LLC
Aug 10, 2022 Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT P... cGMP deviation: Product held outside of appropriate temperature storage conditions. Class II Family Dollar Stores, 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.