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
- Affected units
- 55,272
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.
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
Same brand · FEBUXOSTAT
- ModerateFebuxostat tablets recalled due to microbial contamination in manufacturing
FDA (Drugs) · 2024-03-20
- HighPrescription drug Febuxostat recalled due to manufacturing contamination
FDA (Drugs) · 2024-03-20
- ModeratePrescription Drug Febuxostat Recalled Due to Manufacturing Practice Violations
FDA (Drugs) · 2024-02-14
- HighFebuxostat 80 mg prescription tablets recalled for manufacturing contamination
FDA (Drugs) · 2024-01-31
Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC
See all →- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08
- HighPerampanel Prescription Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-07-01
- HighBudesonide inhalation ampules contain black and brown specks and particles
FDA (Drugs) · 2026-06-17
- SevereDoxorubicin liposome injection vials contain glass particulate matter
FDA (Drugs) · 2026-06-17
Same hazard · microbial contamination
See all →- HighMedline IV Start Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Blood Culture Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Eye and Cataract Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09