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 Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
CGMP Deviations
CGMP Deviations
cGMP Deviations
CGMP Deviations
Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro…
Defective Delivery System: Sustained trend of failure to dispense complaints.
CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.
CGMP Deviations
Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
GMP Deviations: Potential to contain 1-propanol.
GMP Deviations: Potential to contain 1-propanol.
Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
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.
