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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

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 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 17,874 FDA drug recalls.

DateProductReasonClassFirm
Mar 24, 2020 Herpes Soap, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 US... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Sperm Booster, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 ... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Skin Lift, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Blood Clot Purger, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Herpes V Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 ... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Nasal Ez, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Reme... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Hernia Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Cellulite Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 ... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Herpes-P, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, ... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Fungo Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Pimples Off Solution 60 ML, Distributed by Herbal Doctor Remedies Alhambra, C... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Acne Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Bleeding Stop, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 ... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 23, 2020 Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceutical... Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule... Class III Mylan Pharmaceuticals Inc.
Mar 23, 2020 Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactu... Failed Dissolution Specifications: Out of specification result during long term testing in Tetrac... Class I Avet Pharmaceuticals, Inc.
Mar 23, 2020 Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactu... Failed Dissolution Specifications: Out of specification result during long term testing in Tetrac... Class I Avet Pharmaceuticals, Inc.
Mar 19, 2020 DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECT... Failed Stability Specifications Class II Jubilant Draximage Inc
Mar 19, 2020 Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lot... Microbial contamination of non-sterile products: positive test for yeast and bacteria. Class II Filltech USA, LLC
Mar 19, 2020 Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25... Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for ... Class II Edge Pharma, LLC
Mar 19, 2020 Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml... Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for ... Class II Edge Pharma, LLC
Mar 19, 2020 Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor... SubPotent Drug: Low out-of-specification results for assay testing. Class II PAI Holdings, LLC. dba Pharmaceutical Associate...
Mar 19, 2020 Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lot... Microbial contamination of non-sterile products: positive test for yeast and bacteria. Class II Filltech USA, LLC
Mar 18, 2020 Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed ... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx ... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aur... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Auro... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bot... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: ... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bot... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bot... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 16, 2020 Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bot... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, F... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL B... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride ... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. A... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, Fo... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tam... Lack of Assurance of Sterility Class II The Medicine Shoppe Pharmacy
Mar 16, 2020 fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe,... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 ... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, ... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare B... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F005... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement ... Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tada... Class I Y-O Management LLC, dba Natural Remedy Store
Mar 16, 2020 ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, 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.