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Browse Drug Recalls

6,252 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,252 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 6,252 FDA drug recalls.

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DateProductReasonClassFirm
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
Feb 4, 2016 Morphine Sulfate 50 mg/ml/Bupivacaine HCL 24 mg/ml, vol. 20 ml syringe, Rx on... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Baclofen 2000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, ... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 20 mg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharm... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 11 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharm... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/, vol. 20 ml syringe, Rx only... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 1.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Phar... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 1 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharm... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml, vol. 20 ml, syringe, Rx only, Har... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml, ... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 10 mg/ml/Fentanyl Citrate 0.15 mg/ml, vol. 40 ml syringe, R... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/ C... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 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, 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 Hydromorphone HCL 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Ph... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 2 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharm... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Baclofen 5000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Sufentanil Cit 200 mcg/ml/Clonidine HCL 1600 mcg/ml, vol. 42 ml syringe, Rx o... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 20 ml syringe, Rx on... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 11.2 mg/ml, vol. 40 ml syringe, Rx... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol.... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Sufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml, vol. 20 ml syringe, Rx only, ... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml, vol. 20 ml syringe Rx on... 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.