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.
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Superpotent Drug: Stability failure for assay at 6 months test time-point.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product…
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Failed Impurities/Degradation Specifications.
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Defective Container: Firm received complaints of broken tube at the seal.
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Microbial Contamination of Non-Sterile 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.
