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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

17,897 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,897 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 17,897 FDA drug recalls.

DateProductReasonClassFirm
Jul 12, 2019 Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophth... CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufactur... Class II H J Harkins Company Inc dba Pharma Pac
Jul 12, 2019 Awake, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedi... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Appetrol Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Pain Stopper, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Glauco-Catar Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 918... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Stone Purger Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 918... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Prostatin Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Edema Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Fungo Off Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Lung Tonic EX Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Detensin, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Smoke End Capsules,Distributed Herbal Doctor Remedies Alhambra, CA 91801-7081... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Stomach Flu Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 9180... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Herpes-V Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 ... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Worm Off, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Dragon Pain Oil, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-708... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Herpes-S, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Baby Saver Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Asma Stopper Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Anemia Off, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-7081 US... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Lung Fixer Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Herpes-G Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Hair Back, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Asthma Balm 60 gram, Distributed by Herbal Doctor Remedies Alhambra, CA 91801... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Yeast Douche Powder, Distributed by Herbal Doctor Remedies Alhambra, CA 91801... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 11, 2019 Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Ste... Labeling: Missing label; Product complaints reported missing bottle label. Class III Lupin Pharmaceuticals Inc.
Jul 11, 2019 CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Ta... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Adult Glycerin Suppositories, Package Size 100-count suppositories, Distribut... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Adult Glycerin Suppositories, Package Size 50-count suppositories, Distribute... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL. OZ. (89 mL) Distributed By: CR... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc. Pittsbu... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspe... Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the a... Class II Tris Pharma Inc.
Jul 11, 2019 Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 CVS Health Glycerin Suppositories, 100- count box, Distributed by:Distributed... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Eczema Lotion Hydrocortisone 1% / Anti-Itch Lotion, 3.5 oz (99.2 g) Distribut... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 1 OZ (28 g) tube. ... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Man... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ (56 g) tube. ... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 CVS Therapeutic Menthol Gel, 8 FL OZ (227 g) Distributed by: CVS Pharmacy, In... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Adult Glycerin Suppositories, Package Size 25-count suppositories, Distribute... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 CVS Health Glycerin Suppositories, 50-count box, Distributed by: CVS Pharmacy... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Children Glycerin Suppositories Laxative for ages 2 to 5. Package Size 25-cou... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 10, 2019 Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berr... Microbial contamination of non-sterile product Class II LNK International, Inc.
Jul 9, 2019 Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20... Lack of Assurance of Sterility: Bags have the potential to leak. Class II Pfizer Inc.
Jul 9, 2019 Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into ... Failed dissolution specifications : failed results at the 3-month stability time point. Class I Jubilant Cadista Pharmaceuticals, Inc.
Jul 9, 2019 Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 ... Lack of Assurance of Sterility: Bags have the potential to leak. Class II Pfizer Inc.
Jul 8, 2019 Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packag... Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due t... Class II Piramal Critical Care, 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.