Aurobindo Pharma USA Cinacalcet Tablets, 90 mg recall — FDA D-0079-2025
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
754 detailed records are currently available in this category.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations
CGMP violations.
cGMP Deviations
CGMP violations.
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Superpotent Drug: Stability failure for assay at 6 months test time-point.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product…
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