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.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Failed impurities/degradation specifications: Failure to water content and impurity
Failed Dissolution Specifications; during stability testing
Failed Dissolution Specifications; during stability testing
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One…
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
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.
