Browse Drug Recalls

1,141 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,141 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 1,141 FDA drug recalls in 2017.

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Date	Product	Reason	Class	Firm
Jun 15, 2017	Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-d...	Lack of Sterility Assurance	Class II	Hospira a Pfizer Company
Jun 15, 2017	Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose...	Lack of Sterility Assurance	Class II	Hospira a Pfizer Company
Jun 15, 2017	Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. ...	Defective container: Oral solution leaking from container.	Class II	Tris Pharma Inc.
Jun 15, 2017	Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4...	Lack of Sterility Assurance	Class II	Hospira a Pfizer Company
Jun 15, 2017	8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 gr...	Lack of Sterility Assurance	Class II	Hospira a Pfizer Company
Jun 13, 2017	CVS Health Baby Eczema Moisturizing Cream(colloidal oatmeal 1.0%), Net Wt. 7....	Microbial Contamination of Non Sterile Products; out of specification Total Plate Count	Class II	Sigan Industries Inc.
Jun 12, 2017	Magnesium Citrate Saline Laxative Cherry Flavored, packaged in a) 10 fl. oz. ...	Presence of foreign substance: glass particle	Class II	Vi-Jon, Inc.
Jun 12, 2017	Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor C...	Superpotent Drug: high out-of-specification result for magnesium.	Class III	Sanofi-Aventis U.S. LLC
Jun 9, 2017	NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10...	Subpotent Drug: found to be below the specification for labeled assay.	Class I	Advanced Pharma Inc.
Jun 9, 2017	NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per m...	Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c...	Class II	Advanced Pharma Inc.
Jun 9, 2017	NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 1...	Subpotent Drug: found to be below the specification for labeled assay.	Class I	Advanced Pharma Inc.
Jun 9, 2017	NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10...	Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c...	Class II	Advanced Pharma Inc.
Jun 9, 2017	NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Steri...	Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c...	Class II	Advanced Pharma Inc.
Jun 9, 2017	NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per m...	Subpotent Drug: found to be below the specification for labeled assay.	Class I	Advanced Pharma Inc.
Jun 9, 2017	NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 1...	Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c...	Class II	Advanced Pharma Inc.
Jun 8, 2017	Diabecline brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 ...	GMP Deviations; FDA inspection found significant manufacturing practices that call into question ...	Class II	Phillips Co.
Jun 8, 2017	Tetracycline-ABC Brand Topical ointment First Aid Antibiotic, tetracycline (3...	GMP Deviations; FDA inspection found significant manufacturing practices that call into question ...	Class II	Phillips Co.
Jun 8, 2017	StingMed Insect bites Skin Protectant. Zinc acetate (.1% by volume), 0.3 fl. ...	GMP Deviations; FDA inspection found significant manufacturing practices that call into question ...	Class II	Phillips Co.
Jun 8, 2017	VenomX, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottles, Skin Protec...	GMP Deviations; FDA inspection found significant manufacturing practices that call into question ...	Class II	Phillips Co.
Jun 8, 2017	StaphWash+Plus+ Skin Protectant, Zinc acetate (.1% by volume), 0.3 fl. oz. (3...	GMP Deviations; FDA inspection found significant manufacturing practices that call into question ...	Class II	Phillips Co.
Jun 8, 2017	TetraStem brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 m...	GMP Deviations; FDA inspection found significant manufacturing practices that call into question ...	Class II	Phillips Co.
Jun 6, 2017	ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and...	Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.	Class I	Andropharm, LLC
Jun 6, 2017	NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered s...	CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manu...	Class II	Bausch & Lomb, Inc.
Jun 6, 2017	ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsu...	Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.	Class I	Andropharm, LLC
Jun 5, 2017	EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squ...	Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eli...	Class I	Bristol-myers Squibb Company
Jun 5, 2017	Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two pla...	Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the...	Class III	L. Perrigo Company
Jun 5, 2017	Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Mu...	Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of...	Class II	Apothecary By Design
Jun 2, 2017	G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 071...	Failed impurities/degradation specifications: This product is being recalled due to out of specif...	Class III	G & W Laboratories, Inc.
Jun 1, 2017	methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 ...	Lack of Assurance of Sterility	Class II	MedPark Pharmacy, LLC
Jun 1, 2017	Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged ...	Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import ...	Class II	American Pharmaceutical Ingredients LLC
Jun 1, 2017	Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Dis...	CGMP Deviations	Class II	Xttrium Laboratories Inc
Jun 1, 2017	Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg, packaged in a...	Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsu...	Class II	Lucid Pharma LLC
Jun 1, 2017	Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive, 1 Tablet pe...	Defective Container: Carton is missing the tablet blister strip and tablet.	Class II	L. Perrigo Company
May 31, 2017	Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manuf...	Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stab...	Class I	Teva Pharmaceuticals
May 30, 2017	BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Onl...	Failed Moisture Limits: Product tested out-of-specification for moisture content.	Class III	Mckesson Packaging Services
May 26, 2017	Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500...	CGMP Deviations: Lack of quality assurance at the API manufacturer.	Class II	American Pharmaceutical Ingredients LLC
May 25, 2017	BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx...	Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bott...	Class I	AstraZeneca Pharmaceuticals, LP
May 25, 2017	CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufa...	Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, t...	Class I	Brian P. Richardson
May 24, 2017	Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distri...	Failed Dissolution Specifications: Low dissolution results were obtained during stability testing	Class III	Shionogi Inc.
May 24, 2017	Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed b...	Presence of foreign substance: The recall was initiated due to black particles being observed whi...	Class III	Shionogi Inc.
May 24, 2017	PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Man...	Failed Dissolution Specifications: Low dissolution results were obtained during stability testing	Class III	Shionogi Inc.
May 22, 2017	Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription P...	Failed Dissolution Specifications: out of specification results observed for low dissolution.	Class II	Dr. Reddy's Laboratories, Inc.
May 22, 2017	Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription P...	Failed Dissolution Specifications: out of specification results observed for low dissolution.	Class II	Dr. Reddy's Laboratories, Inc.
May 22, 2017	Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (...	Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an...	Class II	Global Marketing Enterprises, Inc.
May 22, 2017	Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription P...	Failed Dissolution Specifications: out of specification results observed for low dissolution.	Class II	Dr. Reddy's Laboratories, Inc.
May 22, 2017	Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription P...	Failed Dissolution Specifications: out of specification results observed for low dissolution.	Class II	Dr. Reddy's Laboratories, Inc.
May 19, 2017	Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distr...	Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product ...	Class I	DYNAMIC TECHNICAL FORMULATIONS
May 18, 2017	fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL,...	Lack of assurance of sterility: Product bags leaking at seam.	Class II	SCA Pharmaceuticals
May 18, 2017	Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple...	Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile resi...	Class III	Lantheus MI Radipharmaceuticals Inc.
May 18, 2017	Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx on...	Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually ...	Class II	Forest Laboratories, 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.