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: product may not meet specification limit for assay test.
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability…
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Defective Container: There were customer complaints of cracked and leaking glass vials.
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Subpotent Drug: Low out-of-specification potency result of the drug product.
Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops.
Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
Chemical contamination: Product may be contaminated with a toxic compound.
Chemical Contamination: Naphthalene compound identified in the product after complaints of a petroleum odor.
Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the…
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the 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.
