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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 16, 2015 | Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutu... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jul 16, 2015 | Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutua... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jul 16, 2015 | Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutu... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jul 16, 2015 | Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmac... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jul 16, 2015 | Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmac... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jul 16, 2015 | Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutua... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jul 14, 2015 | Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bott... | Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown... | Class III | KVK-Tech, Inc. |
| Jul 13, 2015 | Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by P... | Subpotent drug | Class III | Perrigo Israel Pharmaceuticals |
| Jul 13, 2015 | Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch,... | Failed dissolution specifications | Class III | Purdue Pharma L.P. |
| Jul 6, 2015 | Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Join... | Subpotent Drug: menthol and methyl salicylate below specification | Class III | BioComp Pharma, Inc. |
| Jul 2, 2015 | CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged... | Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops. | Class III | Bestco, Inc. |
| Jun 30, 2015 | Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-9... | Failed Dissolution Specifications | Class III | GlaxoSmithkline Consmer Healthcare |
| Jun 29, 2015 | HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3... | Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable | Class III | Qualitest Pharmaceuticals |
| Jun 26, 2015 | Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3... | Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. | Class III | American Health Packaging |
| Jun 26, 2015 | METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactu... | Defective Container: Lids on unit dose cups are not fully qualified. | Class III | VistaPharm, Inc. |
| Jun 23, 2015 | Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured... | Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. | Class III | Actavis Laboratories, FL, Inc. |
| Jun 23, 2015 | CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS R... | Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications. | Class III | Abrams Royal Pharmacy II, LLC |
| Jun 18, 2015 | Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for... | Failed Dissolution Specifications: During routine stability testing at the 12 month time point, ... | Class III | Qualitest Pharmaceuticals |
| Jun 5, 2015 | Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (... | CGMP Deviation: Poor container closure of the bulk storage container | Class III | Geritrex Corp |
| Jun 4, 2015 | Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor ach... | Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of t... | Class III | Indiana Botanic Gardens, Inc |
| Jun 4, 2015 | Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 ... | Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth contro... | Class III | Actavis Inc |
| May 27, 2015 | E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil po... | Failed stability specifications:This recall has been initiated due to out of specification result... | Class III | Bracco Diagnostic Inc |
| May 22, 2015 | Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule,... | Failed Stability Specification: out of specification result obtained for the Particle Size Distri... | Class III | Novartis Pharmaceuticals Corp. |
| May 22, 2015 | Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule,... | Failed Stability Specification: out of specification result obtained for the Particle Size Distri... | Class III | Novartis Pharmaceuticals Corp. |
| May 19, 2015 | Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV... | Failed pH Specifications: 12 month stability testing | Class III | Hospira Inc. |
| May 13, 2015 | Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx On... | Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548). | Class III | West-Ward Pharmaceutical Corp. |
| May 7, 2015 | QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For... | Failed Impurities/Degradation Specifications: out of specification test results for an impurity d... | Class III | Teva Pharmaceuticals USA |
| May 6, 2015 | Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a... | Subpotent drug | Class III | Dr. Reddy's Laboratories, Inc. |
| May 6, 2015 | Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in ... | Subpotent drug | Class III | Dr. Reddy's Laboratories, Inc. |
| May 6, 2015 | Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bot... | Subpotent drug | Class III | Dr. Reddy's Laboratories, Inc. |
| May 6, 2015 | Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)... | Subpotent drug | Class III | Dr. Reddy's Laboratories, Inc. |
| May 4, 2015 | Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy R... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Apr 24, 2015 | Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Ma... | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. | Class III | Cipla Limited |
| Apr 20, 2015 | IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02,... | Subpotent Drug: Low out-of-specification potency result of the drug product. | Class III | Akorn, Inc. |
| Apr 18, 2015 | Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100... | Failed Impurities/Degradation Specifications | Class III | Valeant Pharmaceuticals North America LLC |
| Apr 18, 2015 | Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle,... | Failed Impurities/Degradation Specifications | Class III | Valeant Pharmaceuticals North America LLC |
| Apr 15, 2015 | Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 bli... | Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported f... | Class III | Sandoz, Inc |
| Apr 14, 2015 | Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis... | Subpotent Drug: Flurandrenolide is subpotent. | Class III | Actavis Laboratories |
| Apr 10, 2015 | ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe... | Failed pH specification | Class III | Oasis Medical, Inc. |
| Apr 10, 2015 | MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-D... | Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include on... | Class III | Medtech Products, Inc. |
| Apr 7, 2015 | Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, M... | Subpotent drug | Class III | Apotex Inc. |
| Apr 7, 2015 | Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 605... | Subpotent drug | Class III | Apotex Inc. |
| Apr 7, 2015 | Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 6050... | Subpotent drug | Class III | Apotex Inc. |
| Mar 26, 2015 | Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihista... | Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly ... | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Mar 26, 2015 | Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, ... | Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of ... | Class III | Actavis Laboratories, FL, Inc. |
| Mar 25, 2015 | PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10... | Failed Impurities/Degradation Specifications: A stability lot was out of specification for a know... | Class III | Qualitest Pharmaceuticals |
| Mar 24, 2015 | Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, ... | Failed Content Uniformity Specifications: The product may not meet finished product release speci... | Class III | Nomax Inc |
| Mar 24, 2015 | Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Flu... | Failed Content Uniformity Specifications: The product may not meet finished product release speci... | Class III | Nomax Inc |
| Mar 24, 2015 | Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL... | Failed Content Uniformity Specifications: The product may not meet finished product release speci... | Class III | Nomax Inc |
| Mar 11, 2015 | Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outd... | Failed Impurities/Degradation Specifications: out of specification results for a related compound... | Class III | Mylan Pharmaceuticals 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.