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 were stored outside the drug label specifications.
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
CGMP Deviations: products were stored outside the drug label specifications.
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Defective Container: Tube split from side seam
Failed Dissolution Specifications: below specification limits for dissolution.
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
Failed Dissolution Specifications: below specification limits for dissolution.
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
FAILED DISSOLUTION SPECIFICATIONS
Labeling: Missing label: the product tube was missing a label and contained a different formulation.
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Labeling: Missing label: Label missing from some prefilled pens.
FAILED DISSOLUTION SPECIFICATIONS
Presence of particulate matter: particulate identified as a beetle.
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Failed Dissolution Specifications
Failed Dissolution Specifications
Lack of Assurance of Sterility
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Lack of Assurance of Sterility
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.
