Febuxostat tablets recalled due to microbial contamination in manufacturing
Sun Pharmaceutical is recalling 7,488 bottles of Febuxostat 80mg tablets nationwide due to microbial contamination found in manufacturing equipment. No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 a Class II recall with no reported illnesses or injuries. The microbial contamination was identified in manufacturing equipment rather than in the final product itself, and the recall was initiated as a precautionary measure based on manufacturing deviations.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling 7,488 bottles of Febuxostat 80mg tablets (Lot #DNE0894A, expiration 07/31/2025) due to microbial contamination discovered during manufacturing. The contamination was found in stagnant water in a manufacturing equipment duct.
The recalled product was distributed nationwide. Febuxostat is a prescription medication used to treat gout.
The U.S. Food and Drug Administration classified this as a Class II recall. No illnesses or adverse events related to this product have been reported.
The recalled product
- Product
- FEBUXOSTAT (FEBUXOSTAT)
- Brand
- FEBUXOSTAT
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- Hazard
- Affected units
- 7,488
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 (2)
- Lot #: DNE0894A
- Exp 07/31/2025
UPCs (1)
- 0316714060019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by SUN PHARMACEUTICAL INDUSTRIES INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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