Febuxostat 80 mg prescription tablets recalled for manufacturing contamination
Sun Pharmaceutical is recalling Febuxostat 80 mg tablets due to microbial contamination in manufacturing equipment. Approximately 19,992 bottles were distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with manufacturing contamination representing a reasonable probability of adverse health consequences. No illnesses or injuries have been reported, meeting the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling Febuxostat 80 mg tablets due to Good Manufacturing Practice deviations. Microbial contamination was identified in stagnant water located in a duct of the manufacturing equipment.
Approximately 19,992 bottles were distributed nationwide. The affected lots are DNE0867A (expiration date 06/30/2025) and DNE0894B (expiration date 07/31/2025). Tablets are identified by NDC 47335-722-83.
Consumers taking Febuxostat from the recalled lots are advised to contact their healthcare provider or pharmacist regarding this recall and available treatment alternatives. Do not discontinue medication without medical guidance. Return recalled bottles to the dispensing pharmacy.
The recalled product
- Product
- FEBUXOSTAT (FEBUXOSTAT)
- Brand
- FEBUXOSTAT
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- Hazard
- Affected units
- 19,992
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 #s: DNE0867A Exp. 06/30/2025
- DNE0894B Exp. 07/31/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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 11 products in this recall →Related recalls
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