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.

Clear

Date	Product	Reason	Class	Firm
Jan 17, 2018	Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured ...	Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative conta...	Class I	Magno Humphries Laboratories, Inc
Jan 16, 2018	Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius K...	Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related ...	Class III	Fresenius Kabi USA, LLC
Jan 16, 2018	DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Si...	Lack Of Assurance Of Sterility	Class II	Sun Pharmaceutical Industries, Inc.
Jan 12, 2018	HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial,...	Non-Sterility	Class I	The Compounding Pharmacy of America
Jan 12, 2018	Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-U...	Presence of Particulate Matter; contains visible particulate matter identified as mold.	Class I	AuroMedics Pharma LLC
Jan 12, 2018	Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30...	Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 ...	Class II	International Laboratories, Inc.
Jan 12, 2018	Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30...	Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 ...	Class II	International Laboratories, Inc.
Jan 11, 2018	Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tab...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tab...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 ta...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tab...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 table...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplet...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Dist...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounde...	Labeling: Label Error on Declared Strength	Class II	Premier Pharmacy Labs Inc
Jan 11, 2018	Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tab...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tabl...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplet...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 10, 2018	Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit...	CGMP deviations: Ibuprofen is being recalled in response to previous recall	Class II	Spirit Pharmaceuticals, LLC
Jan 10, 2018	Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured fo...	CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intende...	Class II	Hetero Labs, Ltd. - Unit III
Jan 9, 2018	Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Marksans Pharma Inc.
Jan 9, 2018	Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Marksans Pharma Inc.
Jan 9, 2018	Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Marksans Pharma Inc.
Jan 9, 2018	Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Marksans Pharma Inc.
Jan 9, 2018	Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Marksans Pharma Inc.
Jan 9, 2018	Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Marksans Pharma Inc.
Jan 5, 2018	MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (US...	Subpotent	Class I	Advanced Pharma Inc.
Jan 4, 2018	Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: In...	LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogr...	Class I	International Laboratories, LLC
Jan 3, 2018	Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, M...	Failed Dissolution Specifications: Low out of specification results for dissolution during annual...	Class II	AVKARE Inc.
Jan 2, 2018	Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for in...	Presence of Particulate Matter: A confirmed customer report was received for the presence of visi...	Class I	Aurobindo Pharma Ltd.

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.