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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Drug Recalls

14,449 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,449 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 14,449 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Feb 22, 2023 Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 m... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 21, 2023 Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV B... 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 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 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 Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by:... Failed Impurities/Degradation Specifications Class II RISING PHARMACEUTICALS
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 10, 2023 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B.... Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP ... Class II B. Braun Medical Inc.
Feb 10, 2023 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B... Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP ... Class II B. Braun Medical Inc.
Feb 9, 2023 Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
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 9, 2023 allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-c... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons,... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons,... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
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 allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-co... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count c... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Pac... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cart... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count ... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 8, 2023 Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0... Lack of assurance of sterility: Suspected microbial growth present on external label packaging. Class II Apollo Care
Feb 8, 2023 Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Redd... Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bot... Class II Dr. Reddy's Laboratories, Inc.
Feb 7, 2023 Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 1... 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 Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured f... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Tadalafil Tablets, USP, 2.5 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 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 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 Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactur... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Aripiprazole Tablets, USP 15 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 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 Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-4... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 167... 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.
Feb 7, 2023 Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufacture... 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 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.

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.