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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

2,012 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,012 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 2,012 FDA drug recalls.

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DateProductReasonClassFirm
Jan 5, 2016 Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g T... Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which ... Class I Hospira Inc.
Dec 22, 2015 Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray... Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... Class II Grato Holdings, Inc.
Dec 22, 2015 Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Sp... Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... Class II Grato Holdings, Inc.
Dec 22, 2015 Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spr... Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... Class II Grato Holdings, Inc.
Dec 22, 2015 Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical... Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... Class II Grato Holdings, Inc.
Dec 22, 2015 Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml... Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... Class II Grato Holdings, Inc.
Dec 22, 2015 Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, ... Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... Class II Grato Holdings, Inc.
Dec 18, 2015 Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softge... Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg. Class III National Vitamin Co Inc
Dec 8, 2015 Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Genzyme Corporation
Dec 3, 2015 Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 2... Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the la... Class II GlaxoSmithKline, LLC
Nov 19, 2015 NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industri... Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles. Class III Teva Pharmaceuticals USA
Nov 11, 2015 Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma In... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Instituti... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, R... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Ba... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutiona... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, ... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Ind... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 10, 2015 Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuti... Labeling: Not elsewhere classified. NDC number is incorrect on the container. Class III Northwind Pharmaceuticals LLC
Oct 27, 2015 Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ... Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of... Class II Steris Corp
Oct 20, 2015 Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bott... Labeling: Incorrect or Missing Lot AND/OR Exp Date. Class III Teva Pharmaceutical Industries
Oct 19, 2015 HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL ... Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... Class III Oasis Medical, Inc.
Oct 19, 2015 HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001... Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... Class III Oasis Medical, Inc.
Oct 13, 2015 Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine H... Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as a... Class III Rx PAK
Oct 1, 2015 Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric a... Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the... Class III Tribute Pharmaceuticals US Inc.
Oct 1, 2015 Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fen... Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the... Class III Tribute Pharmaceuticals US Inc.
Sep 29, 2015 Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 o... Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be t... Class I Fit Firm and Fabulous
Sep 25, 2015 ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottl... Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets misla... Class I Medline Industries Inc
Sep 25, 2015 ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle,... Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets misla... Class I Medline Industries Inc
Sep 17, 2015 WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External An... Labeling: Incorrect Instructions; The word not is missing from the following sentences "do band... Class II The Mentholatum Co.
Aug 24, 2015 Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distribu... Labeling: Wrong Bar Code Class II C. O. Truxton
Aug 24, 2015 Xcellerator (product not labeled) Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... Class I Novacare, LLC
Aug 24, 2015 TruTrim (product not labeled) Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... Class I Novacare, LLC
Aug 21, 2015 Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone ... Defective Container: Product missing safety seal around the neck of the bottle. The product labe... Class III Akorn, Inc.
Aug 21, 2015 Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx o... Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the... Class III Silarx Pharmaceutical, Inc.
Aug 13, 2015 AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured fo... Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling. Class III Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Jul 16, 2015 Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutu... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jul 16, 2015 Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutua... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jul 16, 2015 Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutu... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jul 16, 2015 Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg ... Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml inst... Class II Safecor Health, LLC
Jul 16, 2015 Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmac... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jul 16, 2015 Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmac... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jul 16, 2015 Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutua... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jun 30, 2015 KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vi... Crystallization; identified as calcium salt of Ketorolac Class II Hospira Inc.
Jun 30, 2015 KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Via... Crystallization; identified as calcium salt of Ketorolac Class II Hospira Inc.
Jun 10, 2015 NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count b... Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an ... Class II AstraZeneca Pharmaceuticals LP
Jun 4, 2015 Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 ... Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth contro... Class III Actavis Inc
May 21, 2015 SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: In... Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey ... Class II Medtech Products, Inc.
May 15, 2015 MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37... Labeling: incorrect or missing lot number and/or expiration date Class II Mallinckrodt, Inc.
May 12, 2015 Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and l... CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer c... Class II Allegiant Health

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.