Sun Pharmaceutical recalls 100mg Morphine Sulfate Extended-Release Tablets (100-count) due to failed dissolution specifications. This may affect medication effectiveness. Check NDC 63304-452-01 and lot number AD16615.
Failed Dissolution Specifications
Sun Pharmaceutical is recalling 100mg Morphine Sulfate Extended-Release Tablets (100-count bottles) because they failed dissolution tests. This could mean the medication doesn't work as intended, which is serious for patients needing pain relief.
The tablets failed dissolution specifications, meaning they may not release the medication properly over time. This could lead to inconsistent pain management or ineffective treatment. However, the recall does not indicate immediate harm to users.
Patients prescribed this medication by a doctor are affected. Those using the product without a prescription or without proper medical supervision are not covered.
Check for the NDC code 63304-452-01 and lot number AD16615 on the bottle. The product is a prescription-only medication sold by Sun Pharmaceutical in the US.
Look for NDC 63304-452-01 and lot number AD16615 on the bottle label.
The recall does not indicate immediate safety concerns, but the product may not work as intended due to failed dissolution specifications.
Check for NDC 63304-452-01 and lot number AD16615 on the bottle label.
The recall does not specify a remedy, so contact your doctor or pharmacist for guidance.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0249-2025 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0249-2025 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.
