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
Apr 7, 2017	Desoximetasone Ointment USP, 0.25%, 15 g tubes, Rx Only, Teligent Pharma, In...	Superpotent Drug	Class III	Teligent, Inc.
Apr 6, 2017	Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Isomeric Pharmacy Solution, LLC
Apr 6, 2017	Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100...	Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expira...	Class II	PharMedium Services, Llc
Apr 6, 2017	Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opth...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Isomeric Pharmacy Solution, LLC
Apr 6, 2017	Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Isomeric Pharmacy Solution, LLC
Apr 6, 2017	Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-...	cGMP Deviations: lack of quality assurance at the API manufacturer.	Class II	Fagron, Inc
Apr 6, 2017	Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100...	Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expira...	Class II	PharMedium Services, Llc
Apr 6, 2017	Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose V...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Isomeric Pharmacy Solution, LLC
Apr 6, 2017	Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Mul...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Isomeric Pharmacy Solution, LLC
Apr 6, 2017	Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Onl...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Isomeric Pharmacy Solution, LLC
Apr 6, 2017	Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg...	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste...	Class II	Isomeric Pharmacy Solution, LLC
Apr 6, 2017	Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-...	cGMP Deviations: lack of quality assurance at the API manufacturer.	Class II	Fagron, Inc
Apr 4, 2017	Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by ...	Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with ill...	Class III	West-Ward Columbus, Inc.
Apr 3, 2017	ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-08...	cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r...	Class II	Medisca, Inc.
Apr 3, 2017	ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100...	cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r...	Class II	Medisca, Inc.
Apr 3, 2017	ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 gram...	cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r...	Class II	Medisca, Inc.
Apr 3, 2017	Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Dr...	Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information a...	Class II	Cell Distributors
Apr 3, 2017	ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b...	cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r...	Class II	Medisca, Inc.
Mar 30, 2017	Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium...	Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister...	Class II	Bayer HealthCare Pharmaceuticals, Inc.
Mar 30, 2017	Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium b...	Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister...	Class II	Bayer HealthCare Pharmaceuticals, Inc.
Mar 30, 2017	Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bic...	Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister...	Class II	Bayer HealthCare Pharmaceuticals, Inc.
Mar 28, 2017	hCG Body Shaper, Highly Purified Human Chorionic Gonadotrophin 5000 IU, Collo...	Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with huma...	Class II	Gary Wood
Mar 28, 2017	LaBri's Body Health Atomic, 60 capsules	Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.	Class I	Envy Me
Mar 28, 2017	PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL b...	Failed Stability Specifications	Class III	Teva Pharmaceuticals USA
Mar 28, 2017	Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units a...	Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability	Class II	Taro Pharmaceuticals U.S.A., Inc.
Mar 24, 2017	Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compoundi...	cGMP Deviations; lack of quality assurance.	Class II	Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 24, 2017	Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compoundin...	cGMP Deviations; lack of quality assurance.	Class II	Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 24, 2017	Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, M...	cGMP Deviations; lack of quality assurance.	Class II	Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 24, 2017	Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufac...	cGMP Deviations; lack of quality assurance.	Class II	Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 24, 2017	Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufacture...	cGMP Deviations; lack of quality assurance.	Class II	Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 24, 2017	Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufac...	cGMP Deviations; lack of quality assurance.	Class II	Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 24, 2017	Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufac...	cGMP Deviations; lack of quality assurance.	Class II	Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 22, 2017	Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles,...	Failed Impurities/Degradation Specifications.	Class III	Novartis Pharmaceuticals Corp.
Mar 22, 2017	Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83)...	Failed Impurities/Degradation Specifications: out of specification results for the related substa...	Class III	Sun Pharmaceutical Industries, Inc.
Mar 22, 2017	Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83)...	Failed Impurities/Degradation Specifications: out of specification results for the related substa...	Class III	Sun Pharmaceutical Industries, Inc.
Mar 22, 2017	Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 20...	Defective Delivery System: Elevated number of units with out of specification results for leak rate.	Class II	GlaxoSmithKline, LLC
Mar 22, 2017	Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun ...	Failed Impurities/Degradation Specifications: out of specification results for the related substa...	Class III	Sun Pharmaceutical Industries, Inc.
Mar 22, 2017	Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in...	Failed Impurities/Degradation Specifications.	Class III	Novartis Pharmaceuticals Corp.
Mar 22, 2017	Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83...	Failed Impurities/Degradation Specifications: out of specification results for the related substa...	Class III	Sun Pharmaceutical Industries, Inc.
Mar 21, 2017	Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) p...	Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi...	Class II	Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Mar 20, 2017	Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638...	Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.	Class III	G & W Laboratories, Inc.
Mar 20, 2017	CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotio...	Discoloration.	Class III	Valeant Pharmaceuticals North America LLC
Mar 20, 2017	Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 03...	Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi...	Class II	Mylan Pharmaceuticals Inc.
Mar 20, 2017	Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 03...	Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi...	Class II	Mylan Pharmaceuticals Inc.
Mar 20, 2017	Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 03...	Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi...	Class II	Mylan Pharmaceuticals Inc.
Mar 20, 2017	Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 03...	Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi...	Class II	Mylan Pharmaceuticals Inc.
Mar 20, 2017	CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 ...	Discoloration.	Class III	Valeant Pharmaceuticals North America LLC
Mar 17, 2017	LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL b...	Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.	Class II	Akorn, Inc.
Mar 17, 2017	Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, D...	Presence of Particulate Matter: Glass	Class II	Shire
Mar 17, 2017	Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx on...	Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be cont...	Class III	Taro Pharmaceuticals U.S.A., 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.