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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

Consumer Safety

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

18,041 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 18,041 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 18,041 FDA drug recalls.

DateProductReasonClassFirm
Jan 15, 2020 AscorbiX (Buffered C) Injection, Ascorbix (30ML) 500MG/ML Injectable, For IV,... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ S... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate I... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Cyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/ML INJECTABLE, For IV, IM... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 ... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate I... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE, For IV, IM ... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 B-COMPLEX 110 INJECTABLE, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose ... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, ... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Testosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Deoxycholic Acid Sodium Injection,DEOXYCHOLIC ACID SODIUM 1.67% INJECTABLE, F... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Hydroxocobalamin Injection, HYDROXOCOBALAMIN 5MG/ML INJECTABLE, For IV, IM ... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 14, 2020 Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, ... Subpotent: Out of specification for assay at the 12-month time point. Class II Pharmaceutical Associates Inc
Jan 14, 2020 Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL ... cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a prev... Class II Sun Pharmaceutical Industries, Inc.
Jan 14, 2020 methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only... Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to rec... Class III Hikma Pharmaceuticals USA Inc.
Jan 14, 2020 Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp.,... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Spectrum Laboratory Products
Jan 14, 2020 Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Sin... cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a prev... Class II Sun Pharmaceutical Industries, Inc.
Jan 10, 2020 NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatat... Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT... Class II Advanced Accelerator Applications USA, Inc.
Jan 10, 2020 ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 430... CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts ... Class II PD-Rx Pharmaceuticals, Inc.
Jan 10, 2020 Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01... Subpotent Class II Letco Medical LLC
Jan 10, 2020 Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.0... CGMP Deviations: Out of specification test result observed during retrospective review of blend u... Class III Lupin Pharmaceuticals Inc.
Jan 7, 2020 Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx On... Failed Impurities/Degradation Specifications: High out of specification results for related compo... Class II AVKARE Inc.
Jan 7, 2020 Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET W... Microbial contamination of non-sterile product. Class III Sigan Industries Inc.
Jan 7, 2020 Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 037... CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the ... Class II Mylan Pharmaceuticals Inc.
Jan 7, 2020 Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Appco Pharma LLC
Jan 7, 2020 Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 037... CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the ... Class II Mylan Pharmaceuticals Inc.
Jan 7, 2020 Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 co... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Preferred Pharmaceuticals, Inc
Jan 7, 2020 Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottl... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Preferred Pharmaceuticals, Inc
Jan 7, 2020 Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Appco Pharma LLC
Jan 6, 2020 Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count... CGMP Deviations: Presence of NDMA impurity detected in product. Class II H J Harkins Company Inc dba Pharma Pac
Dec 27, 2019 Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repacka... Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer... Class I RemedyRepack Inc.
Dec 26, 2019 Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AAA Pharmaceutical, Inc.
Dec 26, 2019 Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP a... Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out ... Class II Lupin Pharmaceuticals Inc.
Dec 26, 2019 Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blis... Failed Impurities/Degradation Specifications; out-of-specification results obtained for related s... Class II Sun Pharmaceutical Industries, Inc.
Dec 26, 2019 Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use bliste... Failed Impurities/Degradation Specifications; out-of-specification results obtained for related s... Class II Sun Pharmaceutical Industries, Inc.
Dec 26, 2019 Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper ... Chemical contamination; out of specification results obtained for equipment cleaning residue rins... Class III Akorn, Inc.
Dec 26, 2019 Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AAA Pharmaceutical, Inc.
Dec 23, 2019 Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per car... Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the prod... Class II GSK Consumer Health, Inc
Dec 20, 2019 BAC 50MCG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 53... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 8MG/CLON 100MCG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. in 20 mL syr... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 40MG/MORP 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HYDROMORPHONE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 5MG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 30MG/FENT 750MCG/HYDROM 15MG/ML (40) INJ in 20 mL syringe Assurance Infu... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 4MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 MORPHINE 18MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 MORPHINE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 9... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Denton Pharma, 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.