Browse Drug Recalls

1,681 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,681 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 1,681 FDA drug recalls in 2018.

Date	Product	Reason	Class	Firm
Dec 7, 2018	Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes,...	GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purif...	Class II	US Pharmaceuticals Inc.
Dec 7, 2018	Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Pa...	Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained dur...	Class III	Sun Pharmaceutical Industries, Inc.
Dec 7, 2018	Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) pa...	GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purif...	Class II	US Pharmaceuticals Inc.
Dec 7, 2018	Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz ...	GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purif...	Class II	US Pharmaceuticals Inc.
Dec 6, 2018	Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle...	Superpotent Drug.	Class II	Pfizer Inc.
Dec 5, 2018	Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in...	Sub-potent	Class II	Pharmedium Services, LLC
Dec 5, 2018	Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% i...	Sub-potent	Class II	Pharmedium Services, LLC
Dec 4, 2018	Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, M...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018	Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manuf...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018	Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bott...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018	Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Ma...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018	Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, M...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018	Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottl...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018	Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic...	Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottl...	Class II	Epic Pharma, LLC
Dec 4, 2018	Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manu...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018	Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, M...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018	Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manuf...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018	Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manu...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018	Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bott...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018	Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018	Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Mylan Laboratories Limited, (Nashik FDF)
Nov 30, 2018	NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged...	Failed Impurities/Degradation Specifications:Out of specification for impurities.	Class III	VistaPharm, Inc.
Nov 30, 2018	Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bo...	Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets f...	Class III	Aurobindo Pharma USA Inc.
Nov 29, 2018	Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable So...	Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per ...	Class I	Advanced Pharma Inc.
Nov 27, 2018	Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufa...	Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule...	Class III	Glenmark Pharmaceuticals Inc., USA
Nov 27, 2018	Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, ...	CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine...	Class II	Teva Pharmaceuticals USA
Nov 27, 2018	Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (...	CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine...	Class II	Teva Pharmaceuticals USA
Nov 27, 2018	Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, ...	CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine...	Class II	Teva Pharmaceuticals USA
Nov 27, 2018	Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093...	CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine...	Class II	Teva Pharmaceuticals USA
Nov 27, 2018	Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (...	CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine...	Class II	Teva Pharmaceuticals USA
Nov 27, 2018	Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093...	CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine...	Class II	Teva Pharmaceuticals USA
Nov 27, 2018	Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-...	CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine...	Class II	Teva Pharmaceuticals USA
Nov 27, 2018	Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-...	CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine...	Class II	Teva Pharmaceuticals USA
Nov 26, 2018	Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ...	Superpotent Drug: recalled lots may have higher concentration of ibuprofen.	Class II	Tris Pharma Inc.
Nov 26, 2018	Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ...	Superpotent Drug: recalled lots may have higher concentration of ibuprofen.	Class II	Tris Pharma Inc.
Nov 26, 2018	infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 m...	Superpotent Drug: recalled lots may have higher concentration of ibuprofen.	Class II	Tris Pharma Inc.
Nov 21, 2018	Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 m...	Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium C...	Class III	QuVa Pharma, Inc.
Nov 20, 2018	Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manu...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i...	Class II	Mylan Pharmaceuticals Inc.
Nov 20, 2018	Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count b...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i...	Class II	Mylan Pharmaceuticals Inc.
Nov 20, 2018	Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manu...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i...	Class II	Mylan Pharmaceuticals Inc.
Nov 20, 2018	Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manuf...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i...	Class II	Mylan Pharmaceuticals Inc.
Nov 20, 2018	Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manu...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i...	Class II	Mylan Pharmaceuticals Inc.
Nov 20, 2018	Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only,...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i...	Class II	Mylan Pharmaceuticals Inc.
Nov 20, 2018	Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i...	Class II	Mylan Pharmaceuticals Inc.
Nov 20, 2018	Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only,...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i...	Class II	Mylan Pharmaceuticals Inc.
Nov 20, 2018	Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./...	Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product	Class II	AVKARE Inc.
Nov 19, 2018	Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South ...	Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro...	Class II	Pharm D Solutions, LLC
Nov 16, 2018	BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%...	cGMP violations noted during the firm's most recent inspection.	Class II	CAO Group, Inc.
Nov 16, 2018	FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, ...	cGMP violations noted during the firm's most recent inspection.	Class II	CAO Group, Inc.
Nov 16, 2018	fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3c...	cGMP violations noted during the firm's most recent inspection.	Class II	CAO Group, 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.