Browse Drug Recalls
1,045 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,045 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 1,045 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Nov 21, 2012 | Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx on... | Subpotent; 22 month stability timepoint | Class III | Hill Dermaceuticals, Inc. |
| Nov 21, 2012 | Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx o... | Subpotent; 12 month stability timepoint | Class III | Hill Dermaceuticals, Inc. |
| Nov 15, 2012 | Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles... | Subpotent; 15 month stability (by mfr) | Class II | Physicians Total Care, Inc. |
| Nov 6, 2012 | VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vi... | Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity... | Class II | Alkermes, Inc. |
| Oct 29, 2012 | Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by ... | Subpotent; 15 month stability | Class II | Alara Pharmaceutical Co |
| Oct 24, 2012 | Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation A... | Product Lacks Stability: These lots are being recalled due to the failure to meet the particle si... | Class III | GlaxoSmithKline, LLC. |
| Oct 24, 2012 | Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 m... | Product Lacks Stability: These lots are being recalled due to the failure to meet the particle si... | Class III | GlaxoSmithKline, LLC. |
| Oct 23, 2012 | ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxida... | Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stabl... | Class III | Estee Lauder Inc |
| Oct 10, 2012 | QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packa... | Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months ... | Class II | American Health Packaging |
| Oct 3, 2012 | Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., M... | Paddock Laboratories, LLC are recalling one lot (2012028142) of Moexipril HCl Tablets 7.5mg (ex... | Class II | Paddock Laboratories, LLC |
| Sep 27, 2012 | Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd B... | Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 mon... | Class II | Dr. Reddy's Laboratories, Inc. |
| Sep 12, 2012 | Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, R... | Impurities/Degradation Products: An out of specification result for a known impurity of the produ... | Class III | Sandoz Incorporated |
| Sep 12, 2012 | Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx... | Impurities/Degradation Products: An out of specification result for a known impurity of the produ... | Class III | Sandoz Incorporated |
| Aug 29, 2012 | BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactu... | Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine v... | Class I | Bristol-myers Squibb Company |
| Aug 17, 2012 | Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by... | Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide... | Class III | Axcentria Pharmaceuticals LLC |
| Aug 14, 2012 | Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phen... | Impurities/Degradation Products: Recalled lots do not meet room temperature stability specificati... | Class III | Actavis Mid Atlantic LLC |
| Aug 14, 2012 | Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate... | Impurities/Degradation Products: Recalled lots do not meet room temperature stability specificati... | Class III | Actavis Mid Atlantic LLC |
| Aug 7, 2012 | Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactu... | Cross Contamination w/Other Products: During stability testing chromatographic review revealed ex... | Class II | Mylan Pharmaceuticals Inc. |
| Jul 25, 2012 | Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, R... | Subpotent; 9-month stability interval | Class II | Lloyd Inc. of Iowa |
| Jul 25, 2012 | Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, R... | Subpotent; 9-month stability interval | Class II | Lloyd Inc. of Iowa |
| Jul 25, 2012 | Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, R... | Subpotent; 9-month stability interval | Class II | Lloyd Inc. of Iowa |
| Jul 25, 2012 | Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, R... | Subpotent; 9-month stability interval | Class II | Lloyd Inc. of Iowa |
| Jul 19, 2012 | Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bott... | Defective Container: A number of Synthroid bottles have a localized thin wall defect on the botto... | Class II | Abbott Laboratories |
| Jul 19, 2012 | Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottl... | Defective Container: A number of Synthroid bottles have a localized thin wall defect on the botto... | Class II | Abbott Laboratories |
| Jul 19, 2012 | Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottl... | Defective Container: A number of Synthroid bottles have a localized thin wall defect on the botto... | Class II | Abbott Laboratories |
| Jun 28, 2012 | Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceutic... | Impurities/Degradation Products: Out of specification results for Related Compound during routine... | Class III | Mylan Pharmaceuticals Inc. |
| May 30, 2012 | Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL,... | Impurities/Degradation Products: exceeded specification at 3 month stability testing | Class II | VistaPharm, Inc. |
| Apr 13, 2012 | Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10... | Presence of Particulate Matter: This product is being recalled due to the discovery of particles ... | Class II | West-ward Pharmaceutical Corp. |
| Apr 13, 2012 | Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 m... | Presence of Particulate Matter: This product is being recalled due to the discovery of particles ... | Class II | West-ward Pharmaceutical Corp. |
| Mar 29, 2012 | buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets... | Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at th... | Class III | McKesson Packaging Services |
| Mar 29, 2012 | buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets... | Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at th... | Class III | McKesson Packaging Services |
| Jul 6, 2011 | Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottl... | Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulos... | Class II | Bausch & Lomb, 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.