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.
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain…
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain…
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
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.
