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 20, 2018 Dr. King's SafeCare Rx Acute Viro Reliever, 2 fl. oz. (59 mL), King Bio, Inc.... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Sporting Edge, 2 fl. oz. (59 mL), Kin... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Allergy & Hay Fever Reliever, 2 fl. o... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Paranoid Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Baby Colic Relief Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Safecare+ AsthmaCare Homeopathic, Not a Rescue Inhaler, 2 fl oz (5... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Heart Regularity Circulation, 2 fl. oz. (59 mL), King ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Foul Bowel, 2 fl. oz. (59 mL), King Bio, Inc., 3 Wests... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCareRx CS-Lung High Potency Homeopathic Formula for Profession... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Dental Plak, 2 fl. oz. (59 mL), King ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Multi-Strain Flu Relief, 59 mL, (liquid/liquid), ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Advanced First Aid, 2 fl. oz. (59 mL)... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 SafeCareRx Nostalgia, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Ashev... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Bladder Formula, 2 fl. oz. (59 mL), K... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Animal Hair & Dander Allergy Relief, ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Regional Allergies Rocky Mtns. U.S., ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx TremorPlex U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Children's Appetite & Weight Control Children High Pot... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 NET Remedies #4 Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer: Ki... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Cold Sores & Herpes Skin, 2 fl. oz. (59 mL), King Bio,... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Appetite Enhancer Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Constitutional Enhancer, 2 fl. oz. (5... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Indigestion Relief, 2 fl. oz. (59 mL), King Bio, Inc.,... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Menopause Relief, 2 fl. oz. (59 mL), ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Allergies Animal Hair & Dander Allergy, 2 fl. oz. (59 ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Dental Plak, 2 fl. oz. (59 mL), King Bio, Inc., 3 West... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Aquaflora High Potency Candida Control Program Homeopathic Formula, Net 16 fl... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Total Mold Allergy Relief, 2 fl. oz. ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Bug Away, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westsid... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx CataCure, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westsid... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx TUBR Miasm, 2 fl. oz. (59 mL), King Bio, Inc., 3 Wests... Microbial contamination Class I King Bio Inc.
Jul 18, 2018 Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Phar... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II MAJOR PHARMACEUTICALS
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bot... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: No... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Northwind Pharmaceuticals LLC
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottl... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Ph... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Northwind Pharmaceuticals LLC
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bot... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured f... Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted... Class II Hetero Labs, Ltd. - Unit III
Jul 18, 2018 Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pha... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Northwind Pharmaceuticals LLC
Jul 18, 2018 Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, R... Failed Tablet/Capsule Specifications: Tablet breakage Class II VENSUN PHARMACEUTICALS INC
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bott... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind P... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Northwind Pharmaceuticals LLC
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pha... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II MAJOR PHARMACEUTICALS
Jul 18, 2018 Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, R... Failed Tablet/Capsule Specifications: Tablet breakage Class II VENSUN PHARMACEUTICALS INC
Jul 17, 2018 Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochloroth... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II A-S Medication Solutions LLC.
Jul 17, 2018 Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottl... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II A-S Medication Solutions LLC.
Jul 17, 2018 Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack,... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II RemedyRepack Inc.
Jul 17, 2018 Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (... CGMP Deviations Class II Longbow First Aid Products Manufactory
Jul 17, 2018 Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (ND... CGMP Deviations Class II Longbow First Aid Products Manufactory

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.