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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
Feb 21, 2023 Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters... CGMP DEVIATIONS Class II Denver Solutions, LLC DBA Leiters Health
Feb 21, 2023 Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiter... CGMP DEVIATIONS Class II Denver Solutions, LLC DBA Leiters Health
Feb 21, 2023 Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV ... CGMP DEVIATIONS Class II Denver Solutions, LLC DBA Leiters Health
Feb 15, 2023 Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL... cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. Class II Azurity Pharmaceuticals, Inc.
Feb 14, 2023 Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles,... CGMP Deviations Class II Pharmedica USA, LLC
Feb 9, 2023 New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain s... cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API. Class II HTO Nevada, Inc.
Feb 9, 2023 Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive ... cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API. Class II HTO Nevada, 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 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 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 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 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 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 Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, R... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Glimepiride Tablets USP, 4 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, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 167... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufa... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactur... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, ND... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufac... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle,... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Aripiprazole Tablets, USP 2 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 20 mg* Rx Only, Packaged as a) 90 Tablets N... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Rosuvastatin Tablets, USP 40 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 Doxazosin Tablets USP, 2 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.

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.