Sun Pharmaceutical recalls Febuxostat 80mg tablets due to microbial contamination in manufacturing equipment. This recall affects RX-only products with NDC 16714-060-01, lot DNE0894A, expiring 07/31/2025. Consumers should check their bottles for the specific lot number.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Sun Pharmaceutical is recalling Febuxostat 80mg tablets (NDC 16714-060-01) because microbial contamination was found in the manufacturing equipment. This recall affects prescription-only products sold in the U.S. with the specific lot number DNE0894A, which expires July 31, 2025. The contamination could pose a health risk if the medication is taken after the recall.
Microbial contamination was detected in stagnant water within the manufacturing equipment. This could lead to harmful bacteria entering the medication during production, potentially causing health issues if the tablets are taken without proper testing.
Prescription patients who have the specific lot number DNE0894A of Febuxostat 80mg tablets (NDC 16714-060-01) are affected. Those with the medication from the manufacturer's batch in Memphis, TN, are most at risk.
Check your Febuxostat 80mg tablets for the lot number DNE0894A and expiration date of 07/31/2025. The product is labeled as NDC 16714-060-01 and is manufactured for Northstar Rx LLC in Memphis, TN.
Look for the lot number DNE0894A and expiration date of 07/31/2025 on your Febuxostat 80mg tablets.
The recall indicates microbial contamination was found in the manufacturing equipment, so the product may not be safe. Consult your healthcare provider for advice.
Check the lot number and expiration date. If you have the specific lot DNE0894A, contact Sun Pharmaceutical for instructions.
Look for the lot number DNE0894A and expiration date of 07/31/2025 on the product label. The NDC code is 16714-060-01.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0369-2024 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0369-2024 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.
