Browse Drug Recalls
1,056 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,056 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 1,056 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Apr 30, 2013 | Levoxyl (levothyroxine sodium) tablets, USP, 75 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, 100 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, 125 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 9, 2013 | 3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Wa... | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated d... | Class II | Total Resources Intl |
| Apr 9, 2013 | (No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: B... | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated d... | Class II | Total Resources Intl |
| Apr 9, 2013 | Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Trav... | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated d... | Class II | Total Resources Intl |
| Apr 2, 2013 | Cetacaine Liquid Topical Anesthetic, Rx Only, a) 14 g bottle (NDC 10223-0202... | Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three ac... | Class II | Cetylite Industries, Inc. |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.150 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 137 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 112 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 150 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP) , 50 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 88 mcg, RX only, 100 tablets ... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
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.