Browse Drug Recalls

1,788 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,788 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 1,788 FDA drug recalls in 2019.

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Date	Product	Reason	Class	Firm
Oct 23, 2019	Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per...	CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.	Class II	Perrigo Company PLC
Oct 23, 2019	Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 t...	CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.	Class II	Perrigo Company PLC
Oct 23, 2019	Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets pe...	CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.	Class II	Perrigo Company PLC
Oct 23, 2019	Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 t...	CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.	Class II	Perrigo Company PLC
Oct 23, 2019	Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per...	CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.	Class II	Perrigo Company PLC
Oct 23, 2019	Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per...	CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.	Class II	Perrigo Company PLC
Oct 23, 2019	Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per...	CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.	Class II	Perrigo Company PLC
Oct 23, 2019	Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 t...	CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.	Class II	Perrigo Company PLC
Oct 23, 2019	Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per ...	CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.	Class II	Perrigo Company PLC
Oct 23, 2019	Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per...	CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.	Class II	Perrigo Company PLC
Oct 23, 2019	Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per ...	CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.	Class II	Perrigo Company PLC
Oct 22, 2019	Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Compan...	CGMP Deviations: Presence of NDMA impurity detected in product.	Class II	Sanofi-Aventis U.S. LLC
Oct 22, 2019	Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, ...	CGMP Deviations: Presence of NDMA impurity detected in product.	Class II	Sanofi-Aventis U.S. LLC
Oct 22, 2019	Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Compa...	CGMP Deviations: Presence of NDMA impurity detected in product.	Class II	Sanofi-Aventis U.S. LLC
Oct 22, 2019	Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan...	CGMP Deviations: Presence of NDMA impurity detected in product.	Class II	Sanofi-Aventis U.S. LLC
Oct 22, 2019	Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sa...	CGMP Deviations: Presence of NDMA impurity detected in product.	Class II	Sanofi-Aventis U.S. LLC
Oct 22, 2019	Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manuf...	Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Ato...	Class III	Apotex Inc.
Oct 22, 2019	Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Compa...	CGMP Deviations: Presence of NDMA impurity detected in product.	Class II	Sanofi-Aventis U.S. LLC
Oct 22, 2019	Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Compan...	CGMP Deviations: Presence of NDMA impurity detected in product.	Class II	Sanofi-Aventis U.S. LLC
Oct 22, 2019	Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan...	CGMP Deviations: Presence of NDMA impurity detected in product.	Class II	Sanofi-Aventis U.S. LLC
Oct 22, 2019	Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts...	Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.	Class II	Glenmark Pharmaceuticals Inc., USA
Oct 22, 2019	Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219,...	CGMP Deviations: Presence of NDMA impurity detected in product.	Class II	Sanofi-Aventis U.S. LLC
Oct 22, 2019	Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan...	CGMP Deviations: Presence of NDMA impurity detected in product.	Class II	Sanofi-Aventis U.S. LLC
Oct 22, 2019	Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan...	CGMP Deviations: Presence of NDMA impurity detected in product.	Class II	Sanofi-Aventis U.S. LLC
Oct 22, 2019	Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chatt...	CGMP Deviations: Presence of NDMA impurity detected in product.	Class II	Sanofi-Aventis U.S. LLC
Oct 22, 2019	Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 c...	Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tada...	Class I	Green Lumber Holdings, LLC
Oct 21, 2019	PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, ...	Incorrect labeling: Incorrect or missing lot and/or exp date	Class III	Nephron Pharmaceuticals Corporation dba Nephron...
Oct 18, 2019	Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg ...	Marketed without an Approved NDA/ANDA	Class II	Basic Reset Inc.
Oct 18, 2019	BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 m...	Marketed without an Approved NDA/ANDA	Class II	Basic Reset Inc.
Oct 18, 2019	BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 75...	Marketed without an Approved NDA/ANDA	Class II	Basic Reset Inc.
Oct 18, 2019	Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 mL bottle, Made in USA ex...	Marketed without an Approved NDA/ANDA	Class II	Basic Reset Inc.
Oct 18, 2019	BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle,...	Marketed without an Approved NDA/ANDA	Class II	Basic Reset Inc.
Oct 18, 2019	Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. o...	Marketed without an Approved NDA/ANDA	Class II	Basic Reset Inc.
Oct 18, 2019	Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. ...	Marketed without an Approved NDA/ANDA	Class II	Basic Reset Inc.
Oct 18, 2019	Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Ph...	Failed Dissolution Specification: Low out of specification dissolution results.	Class II	Mylan Pharmaceuticals Inc.
Oct 18, 2019	Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 ...	Marketed without an Approved NDA/ANDA	Class II	Basic Reset Inc.
Oct 18, 2019	Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Dis...	Marketed without an Approved NDA/ANDA	Class II	Basic Reset Inc.
Oct 18, 2019	Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. ...	Marketed without an Approved NDA/ANDA	Class II	Basic Reset Inc.
Oct 18, 2019	Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 m...	Marketed without an Approved NDA/ANDA	Class II	Basic Reset Inc.
Oct 17, 2019	Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to th...	Labeling: Incorrect or missing package insert.	Class III	Sandoz Inc
Oct 17, 2019	AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 4229...	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	Class II	AVKARE Inc.
Oct 17, 2019	AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 4229...	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	Class II	AVKARE Inc.
Oct 17, 2019	Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Ste...	Labeling: Incorrect or missing package insert.	Class III	Sandoz Inc
Oct 17, 2019	Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx...	Labeling: Incorrect or missing package insert.	Class III	Sandoz Inc
Oct 16, 2019	Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10...	Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.	Class III	Amneal Pharmaceuticals, Inc.
Oct 15, 2019	Viatrexx-Adipose, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorp...	Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri...	Class II	8046255 Canada Inc. DBA Viatrexx
Oct 15, 2019	Viatrexx-Male+, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpor...	Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri...	Class II	8046255 Canada Inc. DBA Viatrexx
Oct 15, 2019	Viatrexx-Neuro, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpor...	Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri...	Class II	8046255 Canada Inc. DBA Viatrexx
Oct 15, 2019	Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio...	Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri...	Class II	8046255 Canada Inc. DBA Viatrexx
Oct 15, 2019	Viatrexx-Relief +, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incor...	Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri...	Class II	8046255 Canada Inc. DBA Viatrexx

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.