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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

18,041 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 18,041 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 18,041 FDA drug recalls.

DateProductReasonClassFirm
May 25, 2018 X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC... CGMP Deviations: products may be contaminated with bacteria. Class II Shadow Holdings DBA Bocchi Labs
May 25, 2018 Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant ... Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a... Class III Jubilant Cadista Pharmaceuticals, Inc.
May 25, 2018 Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic aci... CGMP Deviations: products may be contaminated with bacteria. Class II Shadow Holdings DBA Bocchi Labs
May 25, 2018 Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) t... CGMP Deviations: products may be contaminated with bacteria. Class II Shadow Holdings DBA Bocchi Labs
May 25, 2018 Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL)... CGMP Deviations: products may be contaminated with bacteria. Class II Shadow Holdings DBA Bocchi Labs
May 24, 2018 Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians... Contraceptive Tablets Out of Sequence. Class I Allergan, PLC.
May 24, 2018 Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-coun... Labeling: Missing Label Class III LUPIN SOMERSET
May 22, 2018 READYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloth... Microbial Contamination of a Non-Sterile Product. Class II Medline Industries Inc (Northpoint Services)
May 17, 2018 Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian P... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Comp... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 7K capsules packaged in single packs sold in 24-count boxes, Distributed by S... Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenaf... Class I Shoreside Enterprises Inc.
May 17, 2018 Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridger... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compound... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardi... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Comp... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guard... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatmen... Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulator... Class II Lupin Pharmaceuticals Inc.
May 17, 2018 My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatmen... Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulator... Class II Lupin Pharmaceuticals Inc.
May 17, 2018 Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded G... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-cou... Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenaf... Class I Shoreside Enterprises Inc.
May 17, 2018 Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded G... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Com... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded G... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Magnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. C... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Comp... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 16, 2018 screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g)... CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed ... Class II Ideaz Llc
May 16, 2018 Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches... Microbial contamination of NonSterile Product; FDA analysis returned out of specification results... Class II Inopak Ltd
May 16, 2018 screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g... CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed ... Class II Ideaz Llc
May 15, 2018 Argentum Elixir Colloidal Silver, 50 PPM Homeopathic Infection Fighter, 8 fl... Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops... Class II MBi Distributing Inc. dba MBi Nutraceuticals
May 15, 2018 Stomach Calm, Calms Upset Stomach and Aids in Treatment of Simple Diarrhea, ... Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops... Class II MBi Distributing Inc. dba MBi Nutraceuticals
May 15, 2018 Intestinal Colic Drops, Homeopathic Drops for Temporary Relief of Flatulent C... Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops... Class II MBi Distributing Inc. dba MBi Nutraceuticals
May 15, 2018 Expectorant Cough Syrup, Homeopathic Syrup for Temporary Relief of Cough & Br... Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops... Class II MBi Distributing Inc. dba MBi Nutraceuticals
May 15, 2018 Nausea Drops, Homeopathic Drops for Temporary Relief of Motion Sickness, Morn... Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops... Class II MBi Distributing Inc. dba MBi Nutraceuticals
May 15, 2018 Silver-Zinc Throat Spray, HOMEOPATHIC IMMUNE DEFENSE, 50PPM, 4oz/50 ppm/ 120m... Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops... Class II MBi Distributing Inc. dba MBi Nutraceuticals
May 15, 2018 Teething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teet... Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops... Class II MBi Distributing Inc. dba MBi Nutraceuticals
May 11, 2018 Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 4580... Defective delivery system Class II L. Perrigo Company
May 8, 2018 Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single... Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency Class I Apotex Inc.
May 8, 2018 Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Sing... Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency Class I Apotex Inc.
May 7, 2018 Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Mag... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical 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.