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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

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Apr 28, 2022 alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distr... Failed Dissolution Specifications: low out-of-specification dissolution test results observed. Class II Viatris Inc
Apr 28, 2022 Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx onl... Failed Dissolution Specifications: low out of specification results for dissolution. Class II Viatris Inc
Apr 27, 2022 GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solut... Failed Stability Specification Class II Lupin Pharmaceuticals Inc.
Apr 25, 2022 Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462... cGMP deviations Class II Glenmark Pharmaceuticals Inc., USA
Apr 25, 2022 Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, ... CGMP Deviations Class II SCA Pharmaceuticals
Apr 25, 2022 Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manuf... cGMP deviations Class II Glenmark Pharmaceuticals Inc., USA
Apr 25, 2022 Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manu... cGMP deviations Class II Glenmark Pharmaceuticals Inc., USA
Apr 25, 2022 Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharm... CGMP Deviations Class II SCA Pharmaceuticals
Apr 25, 2022 Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceu... CGMP Deviations Class II SCA Pharmaceuticals
Apr 22, 2022 Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23... CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. Class II Pfizer Inc.
Apr 22, 2022 Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23... CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. Class II Pfizer Inc.
Apr 22, 2022 Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 ... CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. Class II Pfizer Inc.
Apr 21, 2022 Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Dist... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufac... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx ... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by:... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expresse... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 TORCO RACING FUELS HAND SANITIZER, Alcohol Antiseptic 80% Topical Solution, H... CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... Class II Torco Race Fuels
Apr 15, 2022 Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs o... Failed Dissolution Specifications Class II Dr. Reddy's Laboratories, Inc.
Apr 15, 2022 Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC... cGMP Deviations Class II Teva Pharmaceuticals USA Inc
Apr 15, 2022 Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-co... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-c... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 13, 2022 ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pha... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Thrombin JMI, Vial 5,000IU 2/diluent, kit, Rx only, MFG: Pfizer NDC 60793-2... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Lidocaine Patch 5%, 30-count box, Rx only, MFG: Teva Pharma USA, NDC 0591-352... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MethyLPREDNISolone Acetate Injectable Suspension, USP, 200mg/5mL (40 mg/mL), ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Cefazolin for injection USP, and Dextrose Injection, USP, 2 g, 50 mL duplex c... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Duraclon (clonidine HCl injection, USP), 1000 mcg/10 mL (100 mcg/mL), 10 mL s... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 GlucaGen (glucagon) for injection, 1 mg per vial, single dose kit, Rx only, M... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MethyLPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Spinal Tray (A4058-25 Spinal Tray 25G Whitacre No Epinephrine), Rx only, Manu... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator, 90 mcg, 200 met... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 EPI-Pen Jr, 2-PAK, (epinephrine injection, USP) Single-Dose Auto-Injectors 0.... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Lidocaine Patch 5%, 30-count carton, Rx only, MFG: Qualitest Products, NDC 06... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL (10 mg/mL), ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.15 mg, packaged in 2... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL (100mcg/mL), Rx only, M... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Geodon for injection (ziprasidone mesylate), 20 mg/mL, 1 mL single dose vial,... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Tetracaine Hydrochloride Ophthalmic Solution, 0.5%, 4 mL bottle, Rx only, MFG... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Xylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MF... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Paracentesis/Thoracentises Tray (10/cs) Rx CRFPED, Lidocaine Hydrochloride US... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Intralipid (I.V. Fat emulsion), 20%, 250 mL bag, Rx only, MFG: Baxter Healthc... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Metronidazole tablets, USP 250 mg, 100-count unit dose box, Rx only, MFG: Maj... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office

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.