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.
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Failed Impurities/Degradation Specifications: during long-term stability testing.
Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.
Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100…
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Labeling: Illegible label. Writing is rubbing off of labels.
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Failed Dissolution Specifications: 6 month time point.
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
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.
