Sun Pharmaceutical recalls Febuxostat 40mg tablets due to microbial contamination in manufacturing equipment. Affected lots expire June 2025 and August 2025. Consumers should check NDC 47335-721-83 and lot numbers.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Sun Pharmaceutical is recalling Febuxostat 40mg tablets that may have microbial contamination from manufacturing equipment. This could pose a health risk if the tablets are taken without proper cleaning.
Microbial contamination occurred in stagnant water within the manufacturing equipment's duct. This could lead to harmful bacteria entering the tablets during production, potentially causing health issues if consumed.
Prescription drug users who have Febuxostat 40mg tablets with lot numbers DNE0866B (expiring June 2025) or DNE1045A/DNE1046B (expiring August 2025). Patients on this medication for conditions like gout are most at risk.
Check the product label for NDC 47335-721-83 and lot numbers DNE0866B (expiring June 2025), DNE1045A, or DNE1046B (expiring August 2025). The tablets are prescription-only and sold in 30-count bottles.
Look for NDC 47335-721-83 and lot numbers DNE0866B (expiring June 2025), DNE1045A, or DNE1046B (expiring August 2025) on the tablet packaging.
The recall indicates a potential microbial contamination risk, but the official notice does not specify if the tablets are safe to take without action.
The recall does not provide specific action steps for consumers, so the official notice does not say.
Check the product label for NDC 47335-721-83 and lot numbers DNE0866B (expiring June 2025), DNE1045A, or DNE1046B (expiring August 2025).
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0264-2024 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0264-2024 from Sun Pharmaceutical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
