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.

Clear
DateProductReasonClassFirm
Nov 22, 2013 Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only. Mfd by: Shasun C... Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of t... Class II Physicians Total Care, Inc.
Nov 15, 2013 BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 co... Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months. Class III Actavis Inc
Nov 14, 2013 Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, L... Failed Stability Specifications: this product is below specification for preservative content. Class III Teva Pharmaceuticals USA, Inc.
Nov 13, 2013 Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, ... Failed Dissolution Specifications: Three lots of product being recalled having failed stability d... Class III Forest Pharmaceuticals Inc
Nov 13, 2013 Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, pa... Failed Dissolution Specifications: Three lots of product being recalled having failed stability d... Class III Forest Pharmaceuticals Inc
Nov 13, 2013 Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) ext... Failed Dissolution Specifications: Three lots of product being recalled having failed stability d... Class III Forest Pharmaceuticals Inc
Nov 7, 2013 Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward ... Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of t... Class II West-Ward Pharmaceutical Corp.
Nov 6, 2013 Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth L... Subpotent Drug: During routine stability testing one tablet was found with tablet weight below sp... Class II Actavis Elizabeth LLC
Nov 6, 2013 Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bot... Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content duri... Class III Sandoz Inc
Nov 4, 2013 Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, R... Failed Dissolution Specification; 8 hr stability timepoint Class III Pfizer Inc.
Oct 28, 2013 Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx onl... Failed Stability Specification; product viscosity and or pH are below specification. Class III Hi-Tech Pharmacal Co., Inc.
Oct 15, 2013 Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administ... Defective Container: A lidding deformity allowed for the product to have out of specification res... Class II VistaPharm, Inc.
Oct 7, 2013 Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules ... Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 m... Class II Amedra Pharmaceuticals LLC
Sep 17, 2013 Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lu... Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was fo... Class II Lupin Pharmaceuticals Inc.
Sep 17, 2013 Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lup... Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was fo... Class II Lupin Pharmaceuticals Inc.
Sep 11, 2013 Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only J... Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a steril... Class II Janssen Pharmaceuticals, Inc.
Sep 9, 2013 Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-1... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 9, 2013 Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The pro... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 9, 2013 Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 9, 2013 Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The prod... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 9, 2013 Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 9, 2013 Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-5... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Jul 19, 2013 Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (... Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibit... Class III Bracco Diagnostics Inc
Jul 18, 2013 ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, ... Microbial Contamination of Non-Sterile Products: This product is being recalled because a stabili... Class III Vi-Jon, Inc.
Jul 2, 2013 Pyridostigmine Bromide Tablets 60 mg, USP Rx Only 100 Tablets, Manufactured a... Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out ... Class II Core Pharma Llc
Jun 24, 2013 Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM ... Subpotent Drug; 15-month stability test station Class II Fresenius Kabi USA, LLC
Jun 18, 2013 Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 coun... Failed Dissolution Specifications: Product is being recalled due to out of specification dissolut... Class II Teva Pharmaceuticals USA, Inc.
Jun 18, 2013 Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 coun... Failed Dissolution Specifications: Product is being recalled due to out of specification dissolut... Class II Teva Pharmaceuticals USA, Inc.
Jun 18, 2013 Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 coun... Failed Dissolution Specifications: Product is being recalled due to out of specification dissolut... Class II Teva Pharmaceuticals USA, Inc.
Jun 13, 2013 Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingre... Failed Stability Specifications: Out of specification results for particle size were obtained at ... Class III Bayer HealthCare Pharmaceuticals Inc.
Jun 7, 2013 VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconsti... CGMP Deviations: product was not manufactured under current good manufacturing practices which co... Class II Sagent Pharmaceuticals Inc
May 28, 2013 Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sul... Failed Stability Specifications: Unable to meet shelf life expiry. Class III Faria Limited LLC dba Sheffield Pharmaceuticals
May 28, 2013 Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Sin... Failed Dissolution Specification; during stability testing Class II Teva Pharmaceuticals USA, Inc.
May 15, 2013 Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. Class III Novartis Consumer Health
May 15, 2013 Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorph... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. Class III Novartis Consumer Health
May 15, 2013 Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 cap... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing Class III Novartis Consumer Health
May 15, 2013 Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextrometho... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing Class III Novartis Consumer Health
May 15, 2013 Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit... Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an ... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
May 15, 2013 Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorph... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. Class III Novartis Consumer Health
May 15, 2013 Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlor... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. Class III Novartis Consumer Health
May 15, 2013 Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorphen... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. Class III Novartis Consumer Health
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL)... Subpotent; 24 month stability test station Class III Hi-Tech Pharmacal Co., Inc.
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer

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.