2,661 recalls, newest first
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason CGMP Deviations: use of an unapproved raw material
Reason CGMP Deviations: use of an unapproved raw material
Reason CGMP Deviations: use of an unapproved raw material
Reason Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
Reason Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Reason Labelling: Illegible label
Reason Failed Dissolution Specifications
Reason Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Reason Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Reason Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Reason Lack of Assurance of Sterility
Reason CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Reason CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit