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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
Aug 2, 2018 Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Be... Lack of assurance of sterility. Class II Pharmcore Inc.
Aug 2, 2018 Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Be... Lack of assurance of sterility. Class II Pharmcore Inc.
Aug 2, 2018 Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale B... Lack of assurance of sterility. Class II Pharmcore Inc.
Aug 1, 2018 Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by... Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impuri... Class II Akorn, Inc.
Aug 1, 2018 Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit ... Failed Dissolution Specifications: Out of specification result for the dissolution test. Class II American Health Packaging
Jul 30, 2018 Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Ph... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II NuCare Pharmaceuticals Inc
Jul 30, 2018 Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit do... Failed Dissolution Specifications Class II MAJOR PHARMACEUTICALS
Jul 30, 2018 Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II NuCare Pharmaceuticals Inc
Jul 30, 2018 Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Ph... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II NuCare Pharmaceuticals Inc
Jul 27, 2018 Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bott... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Bryant Ranch Prepack Inc.
Jul 27, 2018 Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottle... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Bryant Ranch Prepack Inc.
Jul 27, 2018 Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Pack... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Bryant Ranch Prepack Inc.
Jul 26, 2018 Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkin... Carcinogen impurity detected in API used to manufacture drug product. Class II H J Harkins Company Inc dba Pharma Pac
Jul 25, 2018 Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 m... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 m... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Avastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, ... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Labor... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 13... Presence of foreign substance: Potential for glass in the neck area of the glass bottles. Class II Mylan Pharmaceuticals Inc.
Jul 25, 2018 Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 m... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laborator... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, ... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g ... Microbial Contamination of a Non-Sterile Product Class II The Hain Celestial Group, Inc. - Worldwide HQ
Jul 25, 2018 Morphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laborat... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, ... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 DMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 ... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier'... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) I... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laborator... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 24, 2018 Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bot... Defective Container: Tamper Evident foil seal not completely intact. Class II Morton Grove Pharmaceuticals, Inc.
Jul 24, 2018 Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufac... Failed Dissolution Specifications: Class II West-Ward Columbus Inc
Jul 24, 2018 Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufact... Failed Dissolution Specifications: Class II West-Ward Columbus Inc
Jul 24, 2018 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium S... CGMP deviations: Product was released while a hood certification discrepancy was being investigated. Class II PharMEDium Services, LLC
Jul 24, 2018 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in... CGMP deviations: Product was released while a hood certification discrepancy was being investigated. Class II PharMEDium Services, LLC
Jul 24, 2018 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL... CGMP deviations: Product was released while a hood certification discrepancy was being investigated. Class II PharMEDium Services, LLC
Jul 18, 2018 Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Phar... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II MAJOR PHARMACEUTICALS
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bot... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: No... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Northwind Pharmaceuticals LLC
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottl... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Ph... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Northwind Pharmaceuticals LLC
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bot... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured f... Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted... Class II Hetero Labs, Ltd. - Unit III
Jul 18, 2018 Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pha... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Northwind Pharmaceuticals LLC
Jul 18, 2018 Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, R... Failed Tablet/Capsule Specifications: Tablet breakage Class II VENSUN PHARMACEUTICALS INC
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bott... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind P... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Northwind Pharmaceuticals LLC
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pha... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II MAJOR PHARMACEUTICALS
Jul 18, 2018 Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, R... Failed Tablet/Capsule Specifications: Tablet breakage Class II VENSUN PHARMACEUTICALS 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.