Drug Recalls
Recent drug recall reports from the FDA (US) and Health Canada, newest first. Each entry links to the full record -- product description, reason for recall, and severity classification -- refreshed daily.
Safecor Health, LLC
Presence of a Foreign Substance; black particles observed in liquid
Safecor Health, LLC
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability …
Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability …
Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability …
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
PMS-BUSULFAN 6mg/mL
Product quality. Verify if your product is affected. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health c…
B BRAUN MEDICAL INC
Presence of Particulate Matter.
Oasis Medical, Inc.
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Exce…
Ascend Laboratories, LLC
Failed Dissolution Specifications
Golden State Medical Supply Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Golden State Medical Supply Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufa…
Lupin Pharmaceuticals Inc.
Presence of particulate matter: a white thread-like structure in the cartridge
Wisconsin Pharmacal Company
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Lannett Company Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Sterile.H2O
Contamination. Verify if your product is affected. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health con…
Thea Pharma, Inc.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Thea Pharma, Inc.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
JB Chemicals and Pharmaceuticals Ltd
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
CareFusion 213, LLC
Lack of assurance of Sterility: potential product contamination
CareFusion 213, LLC
Lack of assurance of Sterility: potential product contamination
Alcon Research LLC
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Alcon Research LLC
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.