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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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DateProductReasonClassFirm
May 18, 2017 PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentrat... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total ... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volum... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total ... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volum... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Vo... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total ... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx o... GMP Deviation; A foreign stopper was observed during packaging of a lot of product. Class II Hospira Inc., A Pfizer Company
May 17, 2017 Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60m... Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved ... Class III VistaPharm, Inc.
May 17, 2017 Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle... Presence of Foreign Substance: potential presence of plastic particles. Class II X-Gen Pharmaceuticals Inc.
May 16, 2017 Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metere... Defective Delivery System: Elevated number of units with out of specification results for leak rate Class II GlaxoSmithKline, LLC
May 16, 2017 Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewa... Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last... Class I Lupin Limited (Unit 1)
May 15, 2017 Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intrav... Lack of assurance of sterility: customer complaints received for the presence of leaks. Class II Baxter Healthcare Corporation
May 15, 2017 Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose ... Lack of assurance of sterility: customer complaints received for the presence of leaks. Class II Baxter Healthcare Corporation
May 11, 2017 Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American... GMP Deviations: The firm does not include an SOP for testing for out of specifications. Class II AtHome Medical, Inc.
May 10, 2017 Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle ... Failed Dissolution Specifications Class II Zydus Pharmaceuticals USA Inc
May 10, 2017 Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx ... Failed Dissolution Specifications Class II Zydus Pharmaceuticals USA Inc
May 10, 2017 Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC ... Failed Dissolution Specifications Class II Zydus Pharmaceuticals USA Inc
May 9, 2017 Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals ... Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurit... Class III Mylan Pharmaceuticals Inc.
May 9, 2017 Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Str... Failed Stability Specifications: Out of Specification results obtained for preservative Methylpar... Class III Strides Pharma INC
May 8, 2017 HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactur... Superpotent Drug: above specification for the assay. Class III Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
May 5, 2017 GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured... Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA anal... Class I Genetic Edge Compounds LLC
May 5, 2017 AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactu... PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled w... Class III Ascend Laboratories LLC
May 2, 2017 Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufa... CGMP Deviations Class III Lupin Pharmaceuticals Inc.
May 1, 2017 Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment... Failed Impurities/Degradation Specifications: stability testing results did not meet the specific... Class II Allergan Sales, LLC
Apr 28, 2017 Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-... Crystallization: due to the presence of white, crystalline particulates, adhered to the side and ... Class II PAR Sterile Products LLC
Apr 27, 2017 Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems pe... Defective Delivery System: Out of specification for peel force from the release liner specificati... Class III Noven Pharmaceuticals, Inc.
Apr 27, 2017 Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: ... Presence of Foreign Substance: human hair melded into tablet. Class III Hetero USA Inc
Apr 26, 2017 Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 coun... Subpotent Drug; Clavulanic Acid Class III Sandoz Inc
Apr 24, 2017 Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count... Microbial Contamination of Non-Sterile Products Class II Teva Pharmaceuticals USA
Apr 21, 2017 Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Sing... Presence of Particulate Matter: human hair found within an internal sample syringe. Class I Hospira Inc.
Apr 20, 2017 Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit con... Product is being recalled due to low pH value. Class III Akorn, Inc.
Apr 20, 2017 Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactur... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital... Class I C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class I C. O. Truxton
Apr 19, 2017 Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 1... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz... GMP Deviations; product may not meet cGMP requirements Class II Gentell, Inc
Apr 19, 2017 Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, ... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, ... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 1... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count,... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count an... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 18, 2017 BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, suppli... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply

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.