Prescription drug Febuxostat recalled due to manufacturing contamination
Sun Pharmaceutical is recalling 47,520 bottles of Febuxostat 40mg tablets nationwide due to microbial contamination found in manufacturing equipment. The FDA classified this as a Class II recall; 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 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: This is an FDA Class II recall with microbial contamination in pharmaceutical manufacturing equipment. Per the rubric, risk-of-harm products without reported injury receive a High severity score. No illnesses have been reported.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling Febuxostat 40mg tablets manufactured and distributed under the NorthStarx brand. The recall affects 47,520 bottles with lot numbers DNE0865A and DNE0866A, expiring 06/30/2025, distributed nationwide.
The FDA issued a Class II recall after microbial contamination was identified in stagnant water within a duct of manufacturing equipment at the facility in Dadra, India. The contamination was discovered during current good manufacturing practice (CGMP) investigations.
No illnesses or injuries have been reported in connection with this product.
The recalled product
- Product
- FEBUXOSTAT (FEBUXOSTAT)
- Brand
- FEBUXOSTAT
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- Hazard
- Affected units
- 47,520
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: DNE0865A
- DNE0866A
- Exp 06/30/2025
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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