Browse Drug Recalls
6,274 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,274 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 6,274 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 18, 2016 | 1/2 Normal Saline 2000 mL + Sodium Acetate 80 mEq., FOR IV USE ONLY, Baptist ... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Ascorbic Acid 500 mg (1 mL) Syringe, FOR IV USE ONLY, Baptist Health Medical ... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | 70% Ethanol-lock Solution, 2 mL Syringe, FOR IV USE ONLY, Baptist Health Medi... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Vancomycin 1250 mg in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Me... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Bapti... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Milrinone 200 mcg/mL in a) D5W-300 mL, b) D5W-400 mL, c) D5W-500 mL and d) D... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Deferoxamine 2 grams/51 mL NS cassette, FOR SUBCUTANEOUS USE ONLY, Baptist He... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Sodium Chloride 0.9% 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist ... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Meropenem 2 grams in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medi... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Hydromorphone 2 mg/mL (500 mg in 250 mL NS) bag, FOR IV USE ONLY, Baptist Hea... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Water for Injection 1000 mL Bags, FOR IV USE ONLY, Baptist Health Medical Tow... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Piperacillin-Tazobactam 9 grams/NS 302 mL bags, FOR IV USE ONLY, Baptist Heal... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Vancomycin 1500 mg in 270 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Med... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | TPN 1, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Me... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Vancomycin 750 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medi... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Vancomycin 500 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medi... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Clindamycin 900 mg in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Med... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Deferoxamine 4 grams/NS 101 mL Cassette, FOR SUBCUTANEOUS USE ONLY, Baptist H... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Invanz 1 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist He... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Vancomycin 1 grams in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Me... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Nafcillin 12 grams in 322 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Med... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Dobutamine 2000 mcg/mL in a) D5W-500 mL, b) D5W-750 mL, c) D5W-1000 mL, d) D5... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Ceftriaxone 2 gram in 100 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Me... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | D5 1/2 NS 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medi... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe, FOR SUBCUTANE... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Vancomycin 2 grams in 540 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Me... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 2, 2016 | Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, ... | Non-sterility - presence of bacteria confirmed by outside laboratory after day 14. | Class I | Complete Pharmacy and Medical Solutions LLC |
| Mar 25, 2016 | 5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun... | Non-Sterility: fungal contamination due to leaking containers. | Class I | B. Braun Medical Inc |
| Mar 14, 2016 | Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratori... | Lack of Assurance of Sterility: incomplete or missing data regarding production. | Class II | Meditech Laboratories, Inc |
| Mar 14, 2016 | Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection... | Lack of Assurance of Sterility: incomplete or missing data regarding production. | Class II | Meditech Laboratories, Inc |
| Mar 14, 2016 | Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 m... | Lack of Assurance of Sterility: incomplete or missing data regarding production. | Class II | Meditech Laboratories, Inc |
| Mar 3, 2016 | Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle... | Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tigh... | Class II | Dr. Reddy's Laboratories, Inc. |
| Feb 12, 2016 | Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N ... | Lack of Assurance of Sterility | Class II | Walter's Pharmacy |
| Feb 12, 2016 | Edetate Disodium 3% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, ... | Lack of Assurance of Sterility | Class II | Walter's Pharmacy |
| Feb 12, 2016 | Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bo... | Lack of Assurance of Sterility | Class II | Walter's Pharmacy |
| Feb 12, 2016 | Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N ... | Lack of Assurance of Sterility | Class II | Walter's Pharmacy |
| Feb 12, 2016 | Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only,... | Lack of Assurance of Sterility | Class II | Walter's Pharmacy |
| Feb 12, 2016 | Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, ... | Lack of Assurance of Sterility | Class II | Walter's Pharmacy |
| Feb 12, 2016 | Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 4... | Lack of Assurance of Sterility | Class II | Walter's Pharmacy |
| Feb 12, 2016 | Lidocaine Nebulizer 1% Solution, Rx only, Walter's Pharmacy, 401 N 17th St, A... | Lack of Assurance of Sterility | Class II | Walter's Pharmacy |
| Feb 12, 2016 | Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 1... | Lack of Assurance of Sterility | Class II | Walter's Pharmacy |
| Feb 12, 2016 | Tobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, ... | Lack of Assurance of Sterility | Class II | Walter's Pharmacy |
| Feb 12, 2016 | Rose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 1... | Lack of Assurance of Sterility | Class II | Walter's Pharmacy |
| Feb 12, 2016 | Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 ... | Lack of Assurance of Sterility | Class II | Walter's Pharmacy |
| Feb 12, 2016 | Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 4... | Lack of Assurance of Sterility | Class II | Walter's Pharmacy |
| Feb 9, 2016 | TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1... | Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the pr... | Class II | Alcon Research, Ltd. |
| Feb 4, 2016 | Hydromorphone HCL 25 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Phar... | Lack of Assurance of Sterility | Class II | Hartley Medical Center Pharmacy, Incorporated |
| Feb 4, 2016 | Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, vol. 40 ml syringe, Rx ... | Lack of Assurance of Sterility | Class II | Hartley Medical Center Pharmacy, Incorporated |
| Feb 4, 2016 | Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml, vol. 20 ml syringe, Rx... | Lack of Assurance of Sterility | Class II | Hartley Medical Center Pharmacy, Incorporated |
| Feb 4, 2016 | Morphine Sulfate 0.6 mg/ml, vol. 200 ml syringe, Rx only, Hartley Med Ctr P... | Lack of Assurance of Sterility | Class II | Hartley Medical Center Pharmacy, Incorporated |
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.