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.
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 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 →- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
- 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
Same hazard · microbial contamination
See all →- SevereMedtronic Recalls Grafton DBM Allografts Due to Donor Microbial Presence
FDA (Devices) · 2026-10-21
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
Similar recalls
- HighPrescription drug Febuxostat recalled due to manufacturing contamination
FDA (Drugs) · 2024-03-20
- ModerateFebuxostat tablets recalled due to microbial contamination in manufacturing
FDA (Drugs) · 2024-03-20
- ModeratePrescription Drug Febuxostat Recalled Due to Manufacturing Practice Violations
FDA (Drugs) · 2024-02-14
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08
- ModerateFDA Recalls Mislabeled Febuxostat Tablets Due to Label Mixup
FDA (Drugs) · 2014-01-22
- HighRosuvastatin Tablets Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2023-04-12