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.
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Microbial Contamination of Non-Sterile Product
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Failed Stability Specifications: Low Out of Specification results for alcohol content.
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating…
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
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.
