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.
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Cross contamination with other products
Subpotent Drug: reduced efficacy for epinephrine
CGMP deviations
CGMP deviations
CGMP deviations
CGMP deviations
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
CGMP deviations
CGMP deviations
CGMP deviations
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
CGMP deviations
Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Sub-potent Drug
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
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.
