Sun Pharmaceutical recalls 40mg Lisdexamfetamine Dimesylate capsules due to failed dissolution test at 12 months. This may affect medication effectiveness. Check NDC 57664-049-88 and lot numbers AD48709 or AD50894.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Sun Pharmaceutical is recalling 40mg Lisdexamfetamine Dimesylate capsules that failed dissolution tests after 12 months. This could mean the medication doesn't work as intended, so affected users should stop using the capsules and contact their doctor.
The capsules failed dissolution tests after 12 months of storage at 25°C and 60% humidity. This means the medication might not release properly in the body, potentially reducing effectiveness.
People with prescriptions for Lisdexamfetamine Dimesylate capsules from Sun Pharmaceutical. Those who have the specific NDC 57664-049-88 lot numbers AD48709 or AD50894 are most at risk.
Check for the NDC code 57664-049-88 on the bottle. Look for lot numbers AD48709 (expires 4/30/2026) or AD50894 (expires 5/31/2026).
Look for the NDC code 57664-049-88 and lot numbers AD48709 or AD50894 on the bottle.
The capsules failed dissolution tests after 12 months of storage at 25°C and 60% humidity, which may affect medication effectiveness.
Check for the NDC code 57664-049-88 and lot numbers AD48709 (expires 4/30/2026) or AD50894 (expires 5/31/2026).
The recall is for potential effectiveness issues, not immediate safety risks. Consult your doctor if you have the recalled product.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0147-2026 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0147-2026 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.
