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.
10,690 detailed records are currently available in this category.
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Carcinogen impurity detected in API used to manufacture drug product.
Failed Dissolution Specifications
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Failed Tablet/Capsule Specifications: Tablet breakage
Failed Stability Specifications: lot out of specification for elevated water vapor.
Failed Tablet/Capsule Specifications: Tablet breakage
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the…
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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.
