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.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Failed Impurities/Degradation Specifications
cGMP deviations
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Failed Impurities/Degradation Specifications
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Lack of Assurance of Sterility
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
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.
