Browse Drug Recalls

1,702 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,702 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 1,702 FDA drug recalls, Class III.

Clear
DateProductReasonClassFirm
Jul 12, 2017 Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlor... Crystallization with subpotent out of specification assay results for chlorhexidine. Class III Akorn Inc
Jul 12, 2017 Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose ... Crystallization with subpotent out of specification assay results for chlorhexidine. Class III Akorn Inc
Jul 12, 2017 Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlor... Crystallization with subpotent out of specification assay results for chlorhexidine. Class III Akorn Inc
Jul 12, 2017 Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL... CGMP Deviations: Firm failed to control impurity for color change at the API stage. Class III Pfizer Inc.
Jul 11, 2017 Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC ... Failed Impurities/Degradation Specifications: high out of specification results for related impur... Class III Dr. Reddy's Laboratories, Inc.
Jul 6, 2017 Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Onl... Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-re... Class III Hospira Inc., A Pfizer Company
Jun 29, 2017 Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bot... Failed Impurities/Degradation Specifications: out of specification test results for related comp... Class III Teva Pharmaceuticals USA
Jun 29, 2017 Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle... Failed Impurities/Degradation Specifications: out of specification test results for related comp... Class III Teva Pharmaceuticals USA
Jun 28, 2017 Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only,... Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being ... Class III Valeant Pharmaceuticals North America LLC
Jun 22, 2017 Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, M... Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 mon... Class III Lupin Pharmaceuticals Inc.
Jun 16, 2017 Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 07... Cross Contamination With Other Product: Imipramine Class III Sandoz Incorporated
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 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 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.
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 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 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 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 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 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 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 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 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 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.
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 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 26, 2017 Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 coun... Subpotent Drug; Clavulanic Acid Class III Sandoz Inc
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 18, 2017 Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, ... Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness. Class III Sun Pharmaceutical Industries, Inc.
Apr 17, 2017 Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pi... Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel.... Class III Fagron, Inc
Apr 17, 2017 Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgel... Subpotent: This product is being recalled due to low out of specification assay results at the 9... Class III P & L Development, LLC
Apr 7, 2017 Desoximetasone Ointment USP, 0.25%, 15 g tubes, Rx Only, Teligent Pharma, In... Superpotent Drug Class III Teligent, 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.
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 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 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, 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 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 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 Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles,... Failed Impurities/Degradation Specifications. Class III Novartis Pharmaceuticals Corp.
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 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 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 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.
Mar 16, 2017 Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Phar... Subpotent Drug Class III Fresenius Kabi USA, LLC
Mar 16, 2017 Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Alle... Failed Impurities/Degradation Specifications Class III Allergan Sales, LLC
Mar 7, 2017 Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manuf... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 7, 2017 Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750... Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ... Class III Pfizer Inc
Mar 7, 2017 Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manuf... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, 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.