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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.

Clear
DateProductReasonClassFirm
Aug 26, 2022 TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infu... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, R... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Car... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, ... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, ... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bee... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Ca... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion L... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bee... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Ca... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC,... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusio... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 23, 2022 Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distribute... CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ing... Class II Teva Pharmaceuticals USA Inc
Aug 22, 2022 Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured ... Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... Class II CIPLA
Aug 22, 2022 Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured ... Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... Class II CIPLA
Aug 17, 2022 Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By ... CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of ef... Class II Padagis US LLC
Aug 15, 2022 Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99... Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the compone... Class II Ultra Chem Labs Corp
Aug 15, 2022 Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99... Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the compone... Class II Ultra Chem Labs Corp
Aug 10, 2022 Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mm... CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. Class II Nephron Sterile Compounding Center LLC
Aug 10, 2022 Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Per... cGMP deviation: Product held outside of appropriate temperature storage conditions. Class II Family Dollar Stores, Llc.
Aug 10, 2022 PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL ... CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. Class II Nephron Sterile Compounding Center LLC
Aug 10, 2022 Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT P... cGMP deviation: Product held outside of appropriate temperature storage conditions. Class II Family Dollar Stores, Llc.
Aug 10, 2022 Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL... cGMP Deviations: deviations leading to potential cross-contamination. Class II Nephron Sc Inc
Aug 10, 2022 Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net W... cGMP deviation: Product held outside of appropriate temperature storage conditions. Class II Family Dollar Stores, Llc.
Aug 10, 2022 Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevent... cGMP deviation: Product held outside of appropriate temperature storage conditions. Class II Family Dollar Stores, Llc.
Aug 10, 2022 Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT P... cGMP deviation: Product held outside of appropriate temperature storage conditions. Class II Family Dollar Stores, Llc.
Aug 10, 2022 PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Via... CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. Class II Nephron Sterile Compounding Center LLC
Aug 10, 2022 PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Un... CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. Class II Nephron Sterile Compounding Center LLC
Aug 10, 2022 Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 47... cGMP deviation: Product held outside of appropriate temperature storage conditions. Class II Family Dollar Stores, Llc.
Aug 8, 2022 Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride ... CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride. Class II Midlab Incorporated
Aug 8, 2022 Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a)... CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride. Class II Midlab Incorporated
Aug 4, 2022 Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container b... Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets ind... Class II Baxter Healthcare Corporation
Aug 2, 2022 Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 ... Lack of Assurance of Sterility: Complaints received of defective container closure. Class II CIPLA
Aug 1, 2022 PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TE... Defective Container: Product has incomplete induction seals. Class II Akorn, Inc
Jul 28, 2022 Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured ... CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity. Class II Lupin Pharmaceuticals Inc.
Jul 27, 2022 Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar ... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Jul 27, 2022 Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-coun... Failed dissolution specifications. Class II Amneal Pharmaceuticals of New York, LLC
Jul 25, 2022 FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV b... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 25, 2022 Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in ... Discoloration Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jul 25, 2022 fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) ... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 21, 2022 Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-coun... Failed Dissolution Specifications: below specification limits for dissolution. Class II Teva Pharmaceuticals USA Inc
Jul 21, 2022 Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-coun... Failed Dissolution Specifications: below specification limits for dissolution. Class II Teva Pharmaceuticals USA Inc
Jul 19, 2022 Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ.... Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol Class II Tsm Brands LLC
Jul 19, 2022 Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: St... Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets Class II Strides Pharma Inc.
Jul 19, 2022 Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM B... Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol Class II Tsm Brands LLC
Jul 18, 2022 Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: J... Failed Dissolution Specifications Class II Jubilant Cadista 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.