Browse Drug Recalls
2,085 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,085 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 2,085 FDA drug recalls in 2013.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 21, 2013 | TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No.... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX... | Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due t... | Class I | Baxter Healthcare Corp. |
| Nov 21, 2013 | 0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB C... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx... | Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to... | Class I | Baxter Healthcare Corp. |
| Nov 21, 2013 | Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 m... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Containe... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 19, 2013 | vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules... | Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in... | Class I | Vitality Research Labs LLC |
| Nov 19, 2013 | NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack... | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared activ... | Class I | Tendex |
| Nov 19, 2013 | P-BOOST Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack ... | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared activ... | Class I | Tendex |
| Nov 18, 2013 | Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Dis... | Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary ... | Class I | SS Wholesale Inc. dba Jobbers Wholesale |
| Nov 18, 2013 | Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1... | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Class I | Baxter Healthcare Corp. |
| Nov 18, 2013 | MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterpr... | Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a diet... | Class I | SS Wholesale Inc. dba Jobbers Wholesale |
| Nov 18, 2013 | Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% De... | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Class I | Baxter Healthcare Corp. |
| Nov 18, 2013 | RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fo... | Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclar... | Class I | Fossil Fuel Products, LLC |
| Nov 18, 2013 | KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division o... | Failed Impurities/Degradation Specifications: Out-of-Specification degradant results. | Class III | Fougera Pharmaceuticals Inc. |
| Nov 18, 2013 | Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL... | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Class I | Baxter Healthcare Corp. |
| Nov 18, 2013 | eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Compan... | Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietar... | Class I | SS Wholesale Inc. dba Jobbers Wholesale |
| Nov 18, 2013 | 50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass conta... | Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and ... | Class I | Baxter Healthcare Corp. |
| Nov 16, 2013 | Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy... | Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Na... | Class II | Tower Pharmacy and Compounding |
| 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), 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 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), 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 | Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/St... | Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with... | Class I | Brookfield Prescription Center Inc |
| Nov 12, 2013 | 10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for ... | Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be... | Class II | Baxter Healthcare Corp. |
| Nov 8, 2013 | PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple ... | Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinica... | Class III | Fresenius Kabi USA, LLC |
| Nov 8, 2013 | Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufacture... | Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Val... | Class II | Teva Pharmaceuticals USA, Inc. |
| Nov 7, 2013 | Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Die... | Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this di... | Class I | Deseo Rebajar |
| 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 | 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 6, 2013 | Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefill... | Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which p... | Class II | GlaxoSmithKline, LLC. |
| 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 | Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only... | Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which p... | Class II | GlaxoSmithKline, LLC. |
| Nov 6, 2013 | Carbon Dioxide, USP, Medical Gas, Rx only, Non Flammable Gas 2, in 50 lbs ste... | Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in... | Class II | Airgas Medical Services |
| Nov 5, 2013 | sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Dist... | Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36... | Class II | Greenstone LLC |
| Nov 4, 2013 | Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45... | Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclare... | Class I | IQ Formulations, LLC |
| Nov 4, 2013 | Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300... | Presence of Particulate Matter: Failed the appearance test for the presence of visible particles. | Class I | Alexion Pharmaceuticals, 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. |
| Nov 4, 2013 | Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, ... | Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr... | Class III | Greenstone Llc |
| Nov 1, 2013 | Idoxuridine 0.1% Ophthalmic | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Natures Pharmacy & Compounding Center |
| Nov 1, 2013 | Gentamycin 80mg/1000cc 0.9% NS | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Natures Pharmacy & Compounding Center |
| Nov 1, 2013 | Terbutaline/Ipratropium 0.5mg/2.5ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Natures Pharmacy & Compounding Center |
| Nov 1, 2013 | Acetylcysteine 10% ophthalmic | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Natures Pharmacy & Compounding Center |
| Nov 1, 2013 | PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ON... | Lack of Assurance of Sterility: Sigma-Tau PharmaSource, Inc. is conducting a voluntary recall of ... | Class II | Sigma-Tau Pharmaceuticals, Inc. |
| Nov 1, 2013 | Glutathione 1.25%/Ascorbic 1.25%/DMSO 6.25% | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Natures Pharmacy & Compounding Center |
| Nov 1, 2013 | L-Glutathione inhalation | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Natures Pharmacy & Compounding Center |
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.