Sun Pharmaceutical recalls Mesalamine Delayed-Release Tablets due to microbial contamination in manufacturing equipment. Affected lots expire by March 2025. Consumers should check NDC 63304-175-13 and lot numbers for affected products.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Sun Pharmaceutical is recalling Mesalamine Delayed-Release Tablets that may contain microbial contamination from manufacturing equipment. This could pose a health risk if the tablets are taken as directed.
Microbial contamination occurred in stagnant water within the manufacturing equipment's duct. This could lead to potential health risks if the contaminated tablets are ingested.
People with ulcerative colitis who require Mesalamine Delayed-Release Tablets. Those with the specific lot numbers listed in the recall are most at risk.
Check for the NDC code 63304-175-13 and lot numbers DNE0875A through DNE1148A on the product packaging. The tablets are sold as Rx-only, 120 tablets per bottle, once daily.
Look for the NDC code 63304-175-13 and lot numbers DNE0875A through DNE1148A on the packaging.
Microbial contamination was reported in stagnant water in the manufacturing equipment's duct.
Check the product packaging for the NDC code 63304-175-13 and lot numbers DNE0875A through DNE1148A. If you have the affected lot, contact Sun Pharmaceutical for further instructions.
The recall is due to potential microbial contamination, but the tablets are safe if they are not the affected lot numbers.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0268-2024 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0268-2024 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.
