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.

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DateProductReasonClassFirm
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.