SUN PHARMACEUTICAL INDUSTRIES INC recalls Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical
Sun Pharmaceutical recalls 500mg Mesalamine Extended-Release Capsules due to failed dissolution specifications. This may affect drug effectiveness. Check NDC 63304-089-13 and lot numbers for affected batches.
Lower-risk recall
Failed Dissolution Specifications: Out of specification for dissolution.
Contact the company & request your remedy
What happened, in plain English
Sun Pharmaceutical is recalling 500mg Mesalamine Extended-Release Capsules because they failed dissolution tests. This could mean the medication doesn't work properly when taken as intended. Read more at govinfonow.com/recall/32835-sun-pharmaceutical-mesalamine-capsules-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/32835-sun-pharmaceutical-mesalamine-capsules-recall-failed-dissolution-specifications · Updated September 23, 2026 · FDA enforcement record: FDA #D-0350-2024
Cite this page
“Sun Pharmaceutical Mesalamine Capsules Recall: Failed Dissolution Specifications.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32835-sun-pharmaceutical-mesalamine-capsules-recall-failed-dissolution-specifications. Based on FDA recall #D-0350-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0350-2024%22&limit=1).
Why it’s dangerous
The capsules failed dissolution tests, meaning they may not release the medication properly in the body. This could lead to the drug not working as intended for treating conditions like ulcerative colitis.
Who’s affected
People with prescription mesalamine for inflammatory bowel disease who received this specific capsule product. Those who have the listed lot numbers or expiration dates are most at risk.
How to tell if you have this one
Check the product label for NDC 63304-089-13 and lot numbers like MHD0606A through MHD1087A with specific expiration dates listed in the recall notice.
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC code 63304-089-13 and lot numbers listed in the recall notice.
Questions people ask
Why is this product being recalled?
The capsules failed dissolution specifications, which means they may not release the medication properly in the body.
What should I do if I have this product?
Check the product label for the NDC code 63304-089-13 and lot numbers listed in the recall notice. If you have the affected items, contact Sun Pharmaceutical for guidance.
Is there a risk of serious injury from this product?
The recall is for potential medication effectiveness issues, not a risk of serious injury. The danger level is low_risk.
Contact Sun Pharmaceutical
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0350-2024 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0350-2024 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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Where this comes from
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.
- Official source: FDA Recall #D-0350-2024 (February 5, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0350-2024 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.