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 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.