Browse Drug Recalls

3,430 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,430 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 3,430 FDA drug recalls.

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DateProductReasonClassFirm
Feb 7, 2023 Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-1... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Table... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufac... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 167... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for:... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multi... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Ac... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets ND... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets ND... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Acc... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Ac... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bott... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 1... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Acc... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accor... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 1... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufact... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufact... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vi... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufa... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
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 Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Fr... 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 Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL... cGMP Deviations Class II Frenda Corporation

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.