Browse Drug Recalls

1,020 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,020 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 1,020 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Jul 17, 2015	midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a s...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, LLC
Jul 17, 2015	succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, LLC
Jul 17, 2015	fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, LLC
Jul 17, 2015	fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, LLC
Jul 17, 2015	lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product ...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, LLC
Jul 17, 2015	morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in ...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, LLC
Jul 17, 2015	rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Tot...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, LLC
Jul 17, 2015	HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, LLC
Jul 17, 2015	ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Tot...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, LLC
Jul 17, 2015	morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Prese...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, LLC
Jul 14, 2015	Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bott...	Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown...	Class III	KVK-Tech, Inc.
Jul 7, 2015	Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only...	Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24...	Class II	Kremers Urban Pharmaceuticals, Inc.
Jul 7, 2015	Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only...	Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity ...	Class II	Kremers Urban Pharmaceuticals, Inc.
Jun 30, 2015	Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceu...	Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were ob...	Class II	Mylan Pharmaceuticals Inc
Jun 18, 2015	Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for...	Failed Dissolution Specifications: During routine stability testing at the 12 month time point, ...	Class III	Qualitest Pharmaceuticals
May 27, 2015	E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil po...	Failed stability specifications:This recall has been initiated due to out of specification result...	Class III	Bracco Diagnostic Inc
May 22, 2015	Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule,...	Failed Stability Specification: out of specification result obtained for the Particle Size Distri...	Class III	Novartis Pharmaceuticals Corp.
May 22, 2015	Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule,...	Failed Stability Specification: out of specification result obtained for the Particle Size Distri...	Class III	Novartis Pharmaceuticals Corp.
May 19, 2015	Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV...	Failed pH Specifications: 12 month stability testing	Class III	Hospira Inc.
May 13, 2015	Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx On...	Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).	Class III	West-Ward Pharmaceutical Corp.
May 11, 2015	Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manuf...	Failed Dissolution Specifications: OOS result during stability testing	Class II	Teva Pharmaceuticals USA
May 7, 2015	QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For...	Failed Impurities/Degradation Specifications: out of specification test results for an impurity d...	Class III	Teva Pharmaceuticals USA
Apr 24, 2015	Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. R...	Failed Stability Specifications: Product failed to meet 12 months long term stability specificati...	Class II	Romark Laboratories, L.C.
Apr 15, 2015	Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 bli...	Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported f...	Class III	Sandoz, Inc
Apr 2, 2015	Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 co...	Subpotent Drug: The firm received an out of specification result for Assay (potency was below spe...	Class II	Boehringer Ingelheim Roxane Inc
Mar 26, 2015	Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihista...	Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly ...	Class III	Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Mar 25, 2015	PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10...	Failed Impurities/Degradation Specifications: A stability lot was out of specification for a know...	Class III	Qualitest Pharmaceuticals
Mar 10, 2015	Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by...	Failed Impurities/Degradation Specifications: during long-term stability testing.	Class II	Mutual Pharmaceutical Company, Inc.
Feb 27, 2015	Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bo...	Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.	Class II	Akorn, Inc.
Feb 16, 2015	Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5...	Failed Impurities/Degradation Specifications; 12 month stability testing.	Class III	West-Ward Pharmaceutical Corporation
Feb 12, 2015	EDTA 3% Eye Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, ...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	Laureth-P 1% Injection (Polidocanol), Health Innov Pharmacy, 295 Pinehurst Av...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	Hydroxyurea 100 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, South...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	Dexamethasone 4 mg/mL Iontophoresis, Health Innov Pharmacy, 295 Pinehurst Ave...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	Nexium 2 mg/1 mL Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	Folic Acid 2 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	Voriconazole 1% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Souther...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	Thymol 2% Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	Coconut Oil Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, Southern P...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	Fortified Vancomycin 25 mg/1 mL Opth Drops, Health Innov Pharmacy, 295 Pinehu...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	Levodopa 250 mg NSR Capsules,Health Innov Pharmacy, 295 Pinehurst Ave, Southe...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	HCG 1000 Units/mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southe...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	Testosterone 100 mg/1 mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave,...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	Nystatin 50,000 Units Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, ...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	Boric Acid Vaginal Capsules, Health Innov Pharmacy, 295 Pinehurst Ave, Southe...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	Carvedilol 1.25 mg/mL, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pin...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	17-HP Hydroxyprogesterone 250mg/1ml Injection, Health Innov Pharmacy, 295 Pin...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	Rifampin 25 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern ...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	Warfarin 2.5 ng Lactose Free Caps, Health Innov Pharmacy, 295 Pinehurst Ave, ...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, Inc
Feb 12, 2015	Lansoprazole 3 mg/mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern...	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse...	Class II	Health Innovations Pharmacy, 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.