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 Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Microbial contamination of Non-Sterile Products
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Failed Dissolution Specifications
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
Lack of assurance of sterility:
CGMP Deviations
Failed Dissolution Specifications
CGMP Deviations
Lack of assurance of sterility:
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
CGMP Deviations
Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
CGMP Deviations
Lack of assurance of sterility:
Non-Sterility
Subpotent: Failing Test Results for Epinephrine
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
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.
