Sun Pharmaceutical recalls Febuxostat 80mg tablets due to microbial contamination in manufacturing equipment. Affected lots expire June 2025 and July 2025. Consumers should check NDC 47335-722-83 and lot numbers.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Sun Pharmaceutical is recalling Febuxostat 80mg 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 patients who have received Febuxostat 80mg tablets with lot numbers DNE0867A (expiring June 30, 2025) or DNE0894B (expiring July 31, 2025). Patients taking this medication for conditions like gout should be most concerned.
Check the product label for NDC 47335-722-83 and lot numbers DNE0867A or DNE0894B. The tablets are prescription-only and come in 30-count bottles.
Look for NDC 47335-722-83 and lot numbers DNE0867A or DNE0894B on the bottle.
Sun Pharmaceutical reported microbial contamination in stagnant water within the manufacturing equipment's duct, which could lead to harmful bacteria in the tablets.
The official recall notice does not specify a remedy, so contact Sun Pharmaceutical directly for guidance.
The recall indicates a potential risk due to microbial contamination, but the official notice does not state if the tablets are safe to use without action.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0265-2024 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0265-2024 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.
