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 manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Microbial Contamination of Non-Sterile Products.
Microbial Contamination of Non-Sterile Products.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Microbial Contamination of Non-Sterile Products
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Microbial Contamination of Non-Sterile Products.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
cGMP deviation: Product held outside of appropriate temperature storage conditions.
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.
