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.
Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Discoloration: Firm received complaints of product discoloration and particulates.
CGMP Deviations
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
CGMP Deviations
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability…
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile…
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
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.
