Sun Pharmaceutical recalls 10mg Lisdexamfetamine Dimesylate capsules due to failed dissolution test at 12 months. This may affect medication effectiveness. Check NDC 57664-046-88 and lot numbers.
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 10mg Lisdexamfetamine Dimesylate capsules that failed dissolution tests at 12 months. This could mean the medication doesn't work as intended, so affected users should check their product details.
The capsules failed dissolution tests at 12 months, meaning they may not release the medication properly. This could affect how well the drug works over time, but does not cause immediate harm.
People with prescriptions for Lisdexamfetamine Dimesylate capsules from Sun Pharmaceutical. Those with the specific NDC 57664-046-88 lot numbers are most at risk.
Check for the NDC number 57664-046-88 and lot numbers AD42468 (expires 2/28/2026) or AD48705 (expires 4/30/2026). The product is prescription-only and sold by Sun Pharmaceutical.
Look for the NDC number 57664-046-88 and lot numbers AD42468 or AD48705 on the bottle.
The recall is due to failed dissolution tests at 12 months, which may affect medication effectiveness. The product is not unsafe but could be less effective.
Check for the NDC number 57664-046-88 and lot numbers AD42468 (expires 2/28/2026) or AD48705 (expires 4/30/2026).
The recall does not require immediate action. Check the product details and contact your pharmacist if you have concerns.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0144-2026 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0144-2026 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.
