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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
Jun 10, 2019 Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextrometho... CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Preferred Pharmaceuticals, Inc
Jun 6, 2019 LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles... CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Teva Pharmaceuticals USA
Jun 6, 2019 LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00 CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Teva Pharmaceuticals USA
Jun 5, 2019 Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Exten... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... Class II Sun Pharmaceutical Industries, Inc.
Jun 5, 2019 Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihis... cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL... Class II P & L Developments, LLC
Jun 5, 2019 Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye ... cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL... Class II P & L Developments, LLC
Jun 5, 2019 Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free... cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL... Class II P & L Developments, LLC
Jun 5, 2019 Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extende... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... Class II Sun Pharmaceutical Industries, Inc.
Jun 5, 2019 Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Releas... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... Class II Sun Pharmaceutical Industries, Inc.
Jun 5, 2019 Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Relea... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... Class II Sun Pharmaceutical Industries, Inc.
Jun 3, 2019 Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (... Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly. Class II Glenmark Pharmaceuticals Inc., USA
May 31, 2019 Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 ... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 31, 2019 Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distri... Failed Dissolution Specifications: Out of specification result for dissolution. Class II Chiesi USA, Inc.
May 31, 2019 Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 16... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 31, 2019 Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (4... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 31, 2019 Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 31, 2019 Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), ... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 31, 2019 Ritussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporati... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 31, 2019 ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx o... Failed Dissolution Specifications: Out of specification result for dissolution. Class II Chiesi USA, Inc.
May 31, 2019 Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corpora... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 31, 2019 Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 m... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 30, 2019 Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Spec... Lack of sterility assurance. Class II Surgery Pharmacy Services Inc
May 30, 2019 Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. M... Lack of sterility assurance. Class II Surgery Pharmacy Services Inc
May 28, 2019 Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 ... Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature,... Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection... Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at R... Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injectio... Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection,... Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc. Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc. Lack of Processing Controls. Class II Synthetopes Inc
May 23, 2019 Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop We... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Nandrolone Decanoate 200 mg/mL Injectable, 10 mL vials, Rx only, Pharm D. Sol... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Human Chorionic Gonadotropin 10,000 IU vials, Rx only Pharm D. Solutions 130... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D. Solutions 1304 South L... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Human Chorionic Gonadotropin 12,000 IU vials Pharm D. Solutions 1304 South L... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 130... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only,... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loo... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 Sout... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50m... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 m... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop Wes... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 S... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 13... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop Wes... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Ho... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 m... Complaint received of metal piece identified in the product bottle prior to the reconstitution. Class II Lupin Pharmaceuticals Inc.
May 23, 2019 B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC

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.