Aurobindo Pharma USA Cinacalcet Tablets, 60mg recall — FDA D-0078-2025
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.
10,685 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-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Presence of Particulate Matter: Potential for glass delamination from the vials.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Presence of Particulate Matter: Potential for glass delamination from the vials.
Labeling: Not Elsewhere Classified - Wrong NDC number
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: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Presence of Particulate Matter: Potential for glass delamination from the vials.
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
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.