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.
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Lack of Sterility Assurance
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Lack of Sterility Assurance
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Lack of Sterility Assurance
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Lack of Sterility Assurance
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Lack of Assurance of Sterility; product has the potential to leak.
Lack of Assurance of Sterility; product has the potential to leak.
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Lack of Assurance of Sterility; product has the potential to leak.
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.
