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: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Chemical contamination: Presence of benzene
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual…
Failed Impurities/Degradation Specifications
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag…
Failed pH Specifications
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
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.
