Browse Drug Recalls
1,032 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,032 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 1,032 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 200 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 | Lloyd Thyro-Tab 0.075 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 0.112 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), 100 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) , 75 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 | Lloyd Thyro-Tab 0.088 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 0.125 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 0.100 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) , 125 mcg, RX only, 100 tablet... | 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 0.137 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 0.175 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), 175 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 | Lloyd Thyro-Tab 0.200 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 |
| Mar 22, 2013 | buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablet... | Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour ... | Class III | Actavis South Atlantic LLC |
| Mar 18, 2013 | Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, ... | Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months. | Class II | West-ward Pharmaceutical Corp. |
| Mar 18, 2013 | Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-... | Subpotent Drug: Product did not conform to the 18-month stability test specification for active ... | Class III | Reckitt Benckiser Inc |
| Mar 12, 2013 | Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distribut... | Failed Impurities/Degradation Specifications: 3 month stability testing. | Class III | L. Perrigo Co. |
| Feb 4, 2013 | buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carto... | Failed Stability Specifications; out of specification results at the 9 month stability time point... | Class III | American Health Packaging |
| Jan 16, 2013 | Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use ... | Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point. | Class III | Actelion Pharmaceuticals U.S., Inc. |
| Jan 4, 2013 | buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bot... | Failed Dissolution Specifications; 8-hours for the 18-month stability testing point. | Class III | Actavis Pharmaceuticals |
| Dec 18, 2012 | Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 36... | Failed Dissolution Specification: Out of a specification result occurred during the 3-month stabi... | Class II | Watson Pharmaceuticals |
| Dec 12, 2012 | Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, Fo... | Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-spec... | Class II | Schering-Plough Products, LLC |
| Dec 4, 2012 | Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-... | Failed Dissolution Specifications; 36 month stability timepoint | Class II | West-ward Pharmaceutical Corp. |
| Nov 21, 2012 | Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmac... | Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and descripti... | Class II | 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.