Browse Drug Recalls
1,733 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,733 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 1,733 FDA drug recalls in 2015.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 22, 2015 | c-Budesonide 0.6MG capsules, 60-count bottle, NOT FOR ORAL USE-USE IN NASAL R... | Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used t... | Class II | Solutions Rx Pharmacy |
| 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 15, 2015 | Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Hydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial, Rx only, Lib... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Methadone 10 mg/mL Injection, 10 mL vial, Rx only, Liberty Drug Compound Cent... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Phenol 6% Injectable, 30 mL vial, Rx only, Liberty Drug Compound Center, 195 ... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Hydroxocobalamin (Preserved) 10,000 mcg/mL Injectable, 1 mL vial, Rx only, Li... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug C... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Lidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial, Rx only, Liberty Dr... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, ... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Doxycycline/0.9% NaCl 150 mg/250 mL IV, 250 mL bag, Rx only, Liberty Drug Com... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Papervine/Phentolamine/PGE-1 Injectable, 30 mg/0.5 mg/30 mcg/mL, 2.5 mL vial,... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Doxcycline/0.9% NaCl 150 mg/150 mL IV, 150 mL bag, Rx only, Liberty Drug Comp... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | 17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, L... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liber... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, ... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vial... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Morphine/0.9 % NaCl 1 mg/mL IV, 250 mL bag, Rx only, Liberty Drug Compound C... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL, 2.5 mL vi... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Glycerin (v/v) 72% Injection, 25 mL vial, Rx only, Liberty Drug Compound Cent... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Comp... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag, Rx only, Liberty Drug Co... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Tobramycin 14 mg/mL Ophthalmic Solution, 15 mL bottle, Rx only, Liberty Drug ... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Dexamethasone 24 mg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound ... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Doxycycline/0.9% NaCl 300 mg/500 mL IV, 500 mL bag, Rx only, Liberty Drug Com... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 9 mg/1 mg/0.1 mg/10 mcg/mL... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 12, 2015 | PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrit... | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a pres... | Class I | GC Natural Nutrition, Inc. |
| Jun 10, 2015 | OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manuf... | Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 ... | Class II | The Harvard Drug Group, LLC |
| Jun 10, 2015 | Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. | Class II | Vital Care Compounder |
| Jun 10, 2015 | Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compo... | Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. | Class II | Vital Care Compounder |
| Jun 10, 2015 | NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count b... | Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an ... | Class II | AstraZeneca Pharmaceuticals LP |
| Jun 10, 2015 | Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vit... | Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. | Class II | Vital Care Compounder |
| Jun 8, 2015 | TRI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | ESTRIOL Vaginal Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | METHYLFOLATE Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman... | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | ESTRIOL Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | HUMAN CHORIONIC GONADOTROPIC (HCG) Injection, Rx, compounded by Life Science ... | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | BI-EST Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | BI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | BI-EST Suspensions, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | BI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | ESTRIOL Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | METHYLFOLATE Injection, Rx, compounded by Life Science Pharmacy Inc., Harrima... | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | HUMAN CHORIONIC GONADOTROPIC (HCG) Sublingual Drops, Rx, compounded by Life S... | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | E3 CREAM, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | ESTRIOL Vaginal Creams, Rx, compounded by Life Science Pharmacy Inc., Harrima... | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | ESTRIOL Suppositories, Rx, compounded by Life Science Pharmacy Inc., Harriman... | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | TRI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | BI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy 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.