Browse Drug Recalls

448 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 448 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 448 FDA drug recalls in MI.

Clear

Date	Product	Reason	Class	Firm
Feb 27, 2020	Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit do...	Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q...	Class III	The Harvard Drug Group
Dec 13, 2019	Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-coun...	Failed Dissolution Specifications: High out of specification result observed at stability studies.	Class III	The Harvard Drug Group
Oct 23, 2019	Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 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, 90 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, 8 tablets. [ND...	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, 95 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, 150 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, 65 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, 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
Apr 24, 2019	DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-un...	cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.	Class II	MAJOR PHARMACEUTICALS
Apr 9, 2019	Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister...	Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sild...	Class I	SELECT DISTRIBUTIONS LLC
Jan 10, 2019	Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	MAJOR PHARMACEUTICALS
Dec 20, 2018	LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Torrent Pharma Inc.
Dec 20, 2018	LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Torrent Pharma Inc.
Dec 20, 2018	LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) ...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Torrent Pharma Inc.
Dec 20, 2018	LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) ...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Torrent Pharma Inc.
Dec 20, 2018	LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), ...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Torrent Pharma Inc.
Nov 6, 2018	Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, ...	Presence of foreign substance: Product found to contain metal particles.	Class II	L. Perrigo Company
Sep 11, 2018	Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx ...	Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at th...	Class II	Torrent Pharma Inc.
Aug 31, 2018	NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, package...	CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, ...	Class II	BioLyte Laboratories, LLC
Aug 23, 2018	Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: ...	Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, includ...	Class I	Hellolife
Aug 23, 2018	Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: ...	Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, includ...	Class I	Hellolife
Aug 23, 2018	Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: ...	Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, includ...	Class I	Hellolife
Aug 23, 2018	Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: ...	Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, includ...	Class I	Hellolife
Jul 30, 2018	Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit do...	Failed Dissolution Specifications	Class II	MAJOR PHARMACEUTICALS
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	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
Jun 26, 2018	Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per c...	Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was reca...	Class III	MAJOR PHARMACEUTICALS
Jun 26, 2018	Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per car...	Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was reca...	Class III	MAJOR PHARMACEUTICALS
May 11, 2018	Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 4580...	Defective delivery system	Class II	L. Perrigo Company
Mar 7, 2018	Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (...	Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expirat...	Class II	American Pharmaceutical Ingredients LLC
Mar 7, 2018	Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC...	Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expirat...	Class II	American Pharmaceutical Ingredients LLC
Feb 9, 2018	Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 2...	CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest...	Class II	American Pharmaceutical Ingredients LLC
Feb 9, 2018	Itraconazole USP (Micronized) for prescription compounding, packaged in a) 1...	CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest...	Class II	American Pharmaceutical Ingredients LLC
Feb 9, 2018	Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 585...	CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest...	Class II	American Pharmaceutical Ingredients LLC
Feb 9, 2018	Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8...	CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest...	Class II	American Pharmaceutical Ingredients LLC
Feb 9, 2018	Progesterone USP (Micronized) (Yam) for prescription compounding, packaged i...	CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest...	Class II	American Pharmaceutical Ingredients LLC
Feb 9, 2018	Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g (...	CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest...	Class II	American Pharmaceutical Ingredients LLC
Feb 9, 2018	Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g ...	CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest...	Class II	American Pharmaceutical Ingredients LLC
Feb 9, 2018	Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8...	CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest...	Class II	American Pharmaceutical Ingredients 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.