Sun Pharmaceutical recalls 500mg niacin extended-release tablets due to microbial contamination in manufacturing equipment. Affected lots 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 500mg niacin extended-release tablets that may contain microbial contamination from manufacturing equipment. This could pose a health risk if the tablets are taken.
Microbial contamination was found in stagnant water within the manufacturing equipment. This could lead to harmful bacteria entering the tablets during production, potentially causing health issues if consumed.
Prescription niacin tablets purchased between specific dates from Sun Pharmaceutical. People taking niacin for medical reasons are most at risk.
Check for the product name 'Niacin Extended-Release Tablets, USP 500mg, Rx Only' with 90 tablets per bottle. Look for lot numbers DNE0771A (expiring June 30, 2025), DNE0857A, or DNE0959A (expiring July 31, 2025).
Look for the lot numbers DNE0771A, DNE0857A, or DNE0959A on the bottle.
Microbial contamination was reported in stagnant water in the manufacturing equipment, which could lead to harmful bacteria in the tablets.
The recall record does not specify a remedy, so contact Sun Pharmaceutical for guidance.
Yes, avoid lot numbers DNE0771A (expiring June 30, 2025), DNE0857A, and DNE0959A (expiring July 31, 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-0270-2024 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0270-2024 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.
