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.

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DateProductReasonClassFirm
Nov 1, 2013 Renacidin Irrigation 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 Glutathione 6%/ascorbic 1%/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 Vitamin D (Ergocalciferol) 800 u/ml 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 AMP/M-B12/Pyridox/Methionine Inositol 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 Vancomycin (fortified) 25mg/ml opth 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 5-Fluorouracil 1% ophthal 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 Acetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ (59 mL) b... Defective Delivery System: There is a remote potential that cartons of product could be co-packag... Class II L. Perrigo Co.
Nov 1, 2013 Hydroxocobalamin inj. 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 Testosterone Cypionate 100mg/ml 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 Bladder Instillation 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 Prostaglandin all combinations 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 Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg 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 Testosterone Cypionate 200mg/ml 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 Glutathione Inhalation 200mg/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 Dexamethasone phosphate 24mg/ml inj. 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 Lidocaine 4% Urethral Gel 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 Voriconazole 0.5mg/ml 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 Tetracaine 0.5% ophth. 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 Hydroxyprogesterone Caproate 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 Cyano B-12 (Cmpd) 1000mcg/ml 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 Sodium Bicarbonate 8.4% inj. 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 Cyano B-12 p-f 1000mcg/ml 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 Cyanocobalamin 100mcg/ml injection 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 Voriconazole 1% opthal 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 Tacrolimus (H20-based) 0.03% ophth. 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 Triamcinolone Acetonide 3mg/ml 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 Folic acid (pf) 10mg/cc inj 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 Vit A (olive oil) 0.1% opth. 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 Acetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-pack... Defective Delivery System: There is a remote potential that cartons of product could be co-packag... Class II L. Perrigo Co.
Nov 1, 2013 Tacrolimus 0.02% opth. (H20-based) 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 Methotrexate Intraocular 400mcg 0.1cc 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 Voriconazole 0.5mg/ml 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 Bleomycin Sulfate 1unit/ml 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 EDTA 3% 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 Novarel (IM) 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 Dexamethosone/Tobramycin pf 0.1%/0.3% 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 Dexamethasone (pf) 0.05 % opth. 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 Acetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ (59 mL) ... Defective Delivery System: There is a remote potential that cartons of product could be co-packag... Class II L. Perrigo Co.
Nov 1, 2013 Ethanol 20% ophthal. 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 Papaverine 12mg/phent 1mg/Pros 9mcq/ml 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 Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, ... Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Exten... Class II Greenstone Llc
Nov 1, 2013 Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ ... Defective Delivery System: There is a remote potential that cartons of product could be co-packag... Class II L. Perrigo Co.
Nov 1, 2013 Methylcobalamin 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 Pyridoxine (p-f) 100mg/ml 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 Scopolamine 0.25 opth. 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 5-Fluorouracil pf in methocel 1% opthal 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 Papaverine 1nj 30mg/ml Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... Class II Natures Pharmacy & Compounding Center
Oct 31, 2013 Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fres... Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial... Class II Fresenius Kabi USA, LLC
Oct 28, 2013 Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx onl... Failed Stability Specification; product viscosity and or pH are below specification. Class III Hi-Tech Pharmacal Co., Inc.
Oct 24, 2013 Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe,... Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported thr... Class II Teva Pharmaceuticals USA

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.