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.
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Lack of assurance of sterility. The recall is due to potential contamination
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
Incorrect Product Formulation
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Presence of precipitate
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Lack of Assurance of Sterility
Subpotent Drug
Lack of Assurance of Sterility
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.
