Browse Drug Recalls
6,348 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,348 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 6,348 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 (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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| 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 | 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 | 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 | 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 | 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 | 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 |
| Oct 19, 2013 | 0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 m... | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... | Class II | Specialty Medicine Compounding Pharmacy |
| Oct 19, 2013 | Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofen... | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... | Class II | Specialty Medicine Compounding Pharmacy |
| Oct 19, 2013 | Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Comp... | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... | Class II | Specialty Medicine Compounding Pharmacy |
| Oct 19, 2013 | TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding... | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... | Class II | Specialty Medicine Compounding Pharmacy |
| Oct 19, 2013 | Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding P... | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... | Class II | Specialty Medicine Compounding Pharmacy |
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.