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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
May 18, 2017 PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentrat... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx on... Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually ... Class II Forest Laboratories, LLC
May 18, 2017 fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL,... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx o... GMP Deviation; A foreign stopper was observed during packaging of a lot of product. Class II Hospira Inc., A Pfizer Company
May 18, 2017 ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total ... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Vo... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volum... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total ... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volum... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 17, 2017 Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle... Presence of Foreign Substance: potential presence of plastic particles. Class II X-Gen Pharmaceuticals Inc.
May 16, 2017 Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metere... Defective Delivery System: Elevated number of units with out of specification results for leak rate Class II GlaxoSmithKline, LLC
May 15, 2017 Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose ... Lack of assurance of sterility: customer complaints received for the presence of leaks. Class II Baxter Healthcare Corporation
May 15, 2017 Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intrav... Lack of assurance of sterility: customer complaints received for the presence of leaks. Class II Baxter Healthcare Corporation
May 11, 2017 Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American... GMP Deviations: The firm does not include an SOP for testing for out of specifications. Class II AtHome Medical, Inc.
May 10, 2017 Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC ... Failed Dissolution Specifications Class II Zydus Pharmaceuticals USA Inc
May 10, 2017 Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx ... Failed Dissolution Specifications Class II Zydus Pharmaceuticals USA Inc
May 10, 2017 Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle ... Failed Dissolution Specifications Class II Zydus Pharmaceuticals USA Inc
May 1, 2017 Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment... Failed Impurities/Degradation Specifications: stability testing results did not meet the specific... Class II Allergan Sales, LLC
Apr 28, 2017 Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-... Crystallization: due to the presence of white, crystalline particulates, adhered to the side and ... Class II PAR Sterile Products LLC
Apr 24, 2017 Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count... Microbial Contamination of Non-Sterile Products Class II Teva Pharmaceuticals USA
Apr 20, 2017 Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactur... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 19, 2017 Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz... GMP Deviations; product may not meet cGMP requirements Class II Gentell, Inc
Apr 19, 2017 Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 1... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count an... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count,... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 1... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, ... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, ... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 18, 2017 PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 QUAD MIX 50/30/1/0.2 5ML MDV (CALIF) MCG/MG/MG/MG/ML INJ, Injection, 50mcg/30... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injection, 25mg/mL, Rx only, 25 mL Gl... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 SODIUM CARBOXYM-CELL PF 0.5% OPHTH, opthalmic, 0.50%, Rx only, 10mL Glass/Mul... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 150,000u/mL, Rx only,... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL, Rx only,... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Gl... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 HYDROXO-B12 5ML PBF MDV (CALIF) 10MG/ML INJ, Injection, 10mg/mL, RX only, 5mL... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 TRI MIX 5.95/17.8572/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 5.95mcg/17.85mg... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Mul... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 PAPAVERINE/PHENT 5ML MDV 30/1MG/ML INJ, Injection, 30mg/1mg/mL, Rx only, 5mL ... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 TESTOST CYP SESAME OIL 5ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 5 ... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 HYDROXO-B12 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/ Si... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center

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.