Febuxostat Prescription Tablets Recalled Nationwide for Manufacturing Contamination
Sun Pharmaceutical recalls 55,272 bottles of Febuxostat 40mg tablets nationwide due to microbial contamination detected in manufacturing equipment. No illnesses have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—microbial contamination identified during manufacturing quality review—is preventive rather than evidence-based. Per the rubric, recalls with no reported illness and manufacturing deviations without evidence of actual harm score as Moderate.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling Febuxostat 40mg tablets due to current good manufacturing practice (CGMP) deviations. The FDA Class II recall was initiated after microbial contamination was identified in stagnant water in the manufacturing equipment duct.
The recall affects 55,272 bottles distributed nationwide. Affected lot numbers include DNE0866B (expiration 06/30/2025), DNE1045A, and DNE1046B (expiration 08/31/2025). The product is manufactured in India and distributed from Cranbury, New Jersey.
No illnesses or adverse events have been reported. Consumers should verify whether their Febuxostat matches the affected lot numbers.
The recalled product
- Product
- FEBUXOSTAT (FEBUXOSTAT)
- Brand
- FEBUXOSTAT
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- Hazard
- microbial-contamination
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #s: DNE0866B Exp. 06/30/2025
- DNE1045A
- DNE1046B Exp. 08/31/2025
Distribution
Distributed nationwide across the United States.
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