Browse Drug Recalls

3,394 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,394 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 3,394 FDA drug recalls.

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DateProductReasonClassFirm
Jan 30, 2023 Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Ey... CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because th... Class II Global Pharma Healthcare Private Limited
Jan 30, 2023 Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG i... CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because th... Class II Global Pharma Healthcare Private Limited
Jan 17, 2023 Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged... CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to ... Class II Fisher Scientific Co., LLC
Jan 17, 2023 Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 ... CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to ... Class II Fisher Scientific Co., LLC
Jan 17, 2023 Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 M... CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... Class II Urban Electric Power
Jan 17, 2023 Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles. CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... Class II Urban Electric Power
Jan 12, 2023 Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose... CGMP Deviations: potential for trace amounts of product carryover. Class II Nephron Sc Inc
Jan 12, 2023 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Onl... CGMP Deviations: potential for trace amounts of product carryover. Class II Nephron Sc Inc
Jan 10, 2023 Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle... CGMP Deviations: initiated due to violations of CGMP manufacturing practices Class II Consolidated Chemical, Inc
Jan 10, 2023 Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Sai... CGMP Deviations: initiated due to violations of CGMP manufacturing practices Class II Consolidated Chemical, Inc
Dec 22, 2022 Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular In... CGMP Deviations: Raw material recalled by repackager, due to discoloration. Class II Pine Pharmaceuticals, LLC
Dec 15, 2022 Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8... cGMP Deviations Class II Frenda Corporation
Dec 15, 2022 Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Fr... cGMP Deviations Class II Frenda Corporation
Dec 15, 2022 Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL... cGMP Deviations Class II Frenda Corporation
Dec 15, 2022 Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 m... cGMP Deviations Class II Frenda Corporation
Dec 15, 2022 Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 918... cGMP Deviations Class II Frenda Corporation
Dec 15, 2022 Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (1... cGMP Deviations Class II Frenda Corporation
Dec 15, 2022 Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gall... cGMP Deviations Class II Frenda Corporation
Dec 12, 2022 Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged... cGMP Deviations Class II Atlantic Management Resources Ltd.
Dec 12, 2022 Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g)... cGMP Deviations Class II Atlantic Management Resources Ltd.
Dec 12, 2022 ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 ... cGMP Deviations Class II Atlantic Management Resources Ltd.
Dec 12, 2022 Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g... cGMP Deviations Class II Atlantic Management Resources Ltd.
Dec 9, 2022 Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution,... CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess o... Class II NCH Life Sciences LLC
Dec 7, 2022 Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Phar... CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Class II Lupin Pharmaceuticals Inc.
Dec 7, 2022 Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Phar... CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Class II Lupin Pharmaceuticals Inc.
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 10, 2022 PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only... 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 AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment ... 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 Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manu... 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 Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx O... 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 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL droppe... 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 Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactur... 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 13, 2022 Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufact... 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 GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dro... 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 ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube... 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 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 Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bo... 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.

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.