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.
Asclemed USA Inc.
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Fresenius Kabi USA, LLC
Failed Impurities/Degradations Specifications
IntegraDose Compounding Services LLC
Subpotent Drug
ANI Pharmaceuticals, Inc.
Defective Container; packets were found to be either empty or partially full.
Spectra Medical Devices, Llc
Lack of Assurance of Sterility
SUN PHARMACEUTICAL INDUSTRIES INC
Presence of Particulate matter: Particulate matter identified as glass.
Haleon US Holdings LLC
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Nitrous Oxide whipped cream chargers
Unauthorized product. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any heal…
UCB Biosciences Inc.
Lack of Assurance of Sterility
GHK-Cu & BPC-157 powder
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…
Ascend Laboratories, LLC
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Sagent Pharmaceuticals
Failed Impurities/Degradation Specifications
Amerisource Health Services LLC
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Amerisource Health Services LLC
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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