Sun Pharmaceutical recalls Febuxostat 40mg tablets (NDC 16714-059-01) due to microbial contamination in manufacturing equipment. Affected lots DNE0865A and DNE0866A expire June 2025. Consumers should not use these products.
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 recall affects specific lots produced in India and sold in the U.S. The contamination could pose health risks if the medication is taken.
Microbial contamination was found in stagnant water within the manufacturing equipment's duct system. This could lead to harmful bacteria entering the medication during production, potentially causing health issues if the tablets are taken.
Prescription drug users who purchased Febuxostat 40mg tablets (NDC 16714-059-01) in the U.S. between specific production dates. People with conditions requiring this medication are most at risk.
Check for the product name 'Febuxostat Tablets 40mg', NDC code 16714-059-01, and lot numbers DNE0865A or DNE0866A. These tablets were manufactured for Northstar Rx LLC in Memphis, TN and sold in the U.S. by Sun Pharmaceutical.
Look for the NDC code 16714-059-01 and lot numbers DNE0865A or DNE0866A on the packaging.
Sun Pharmaceutical reported microbial contamination in stagnant water within the manufacturing equipment's duct system.
The recall record does not specify a remedy or action steps for consumers.
The recall indicates potential microbial contamination, but the record does not specify health risks or how serious they are.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0368-2024 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0368-2024 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.
