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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
Sep 10, 2018 Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 QM-4A Quadmix 5 mL 30 PA-2PH-150A-Atropine 0.4 mg Aqueous Solution, Pharm D S... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG 3000 Unit Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1738-10 Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D S... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Calcium Gluconate 1% Eyewash Oph. Soln, 10 mg/mL, 1000 mL bottles, Pharm D So... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Hou... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Lipo MIC-12 Compound Injectable a) NDC 69699-1603-10; b) 30 mL Stock Solution... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable, Pharm D Solutions, ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions, Houston, Texas... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 ... Defective Delivery System: out of specification results for shear, an attribute related to the ad... Class II Noven Pharmaceuticals, Inc.
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 co... Defective Delivery System: out of specification results for shear, an attribute related to the ad... Class II Noven Pharmaceuticals, Inc.
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 co... Defective Delivery System: out of specification results for shear, an attribute related to the ad... Class II Noven Pharmaceuticals, Inc.
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 co... Defective Delivery System: out of specification results for shear, an attribute related to the ad... Class II Noven Pharmaceuticals, Inc.
Sep 6, 2018 0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare ... cGMP Deviation Class II Baxter Healthcare Corporation
Sep 4, 2018 Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Red... Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl T... Class II Dr. Reddy's Laboratories, Inc.
Sep 4, 2018 Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. R... Cross Contamination With Other Products: Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Aug 31, 2018 NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, package... CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, ... Class II BioLyte Laboratories, LLC
Aug 31, 2018 Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per ... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Diarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass or... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Sinus Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral ... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glas... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Muscle & Joint Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Sore Throat & Laryngitis Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) pe... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 30, 2018 Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum,... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Alkano Chemicals, Inc
Aug 28, 2018 Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grai... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Humco Holding Group, Inc
Aug 28, 2018 Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 ... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Humco Holding Group, Inc
Aug 28, 2018 Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grai... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Humco Holding Group, Inc
Aug 24, 2018 Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. ... CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products ... Class II Valeant Pharmaceuticals North America LLC
Aug 24, 2018 Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co.,... CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine a... Class II LGM Pharma LLC
Aug 24, 2018 Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) ... CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products ... Class II Valeant Pharmaceuticals North America LLC
Aug 24, 2018 Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Di... CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products ... Class II Valeant Pharmaceuticals North America LLC
Aug 24, 2018 Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For... Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified ... Class II Akorn, Inc.
Aug 24, 2018 Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in c... CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an act... Class II RemedyRepack Inc.
Aug 23, 2018 Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL O... Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the i... Class II Pfizer Global Supply
Aug 23, 2018 Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a phy... Class II Pacific Compounding Pharmacy & Consultations Inc
Aug 22, 2018 THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothy... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Syntec Pharma Corp
Aug 22, 2018 THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Syntec Pharma Corp
Aug 21, 2018 Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multi... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Co... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 21, 2018 Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Cent... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 m... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical C... CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine... Class II Sichuan Friendly Pharmaceutical Co.,Ltd.
Aug 21, 2018 Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central ... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 m... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Cen... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, 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.