Sun Pharmaceutical recalls 30mg Lisdexamfetamine Dimesylate capsules due to failed dissolution test at 12 months. This may affect drug effectiveness. Check NDC 57664-048-88 and lot numbers for affected products.
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 30mg 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 and follow the recall steps.
The capsules failed dissolution tests during long-term stability testing at 12 months. This means the medication might not release properly in the body, potentially reducing effectiveness. However, the recall does not indicate a safety risk to users.
People with prescriptions for Lisdexamfetamine Dimesylate 30mg capsules from Sun Pharmaceutical. Those who have the specific NDC number or lot numbers listed are most at risk.
Check for the NDC number 57664-048-88 and lot numbers AD42470 (expires 2/28/2026) or AD48708 (expires 4/30/2026) on the product label.
Look for the NDC number 57664-048-88 and lot numbers AD42470 or AD48708 on the capsule packaging.
The capsules failed dissolution tests at 12 months during stability testing, which could affect medication effectiveness.
No, the recall does not require stopping use. The issue is with the medication's effectiveness, not safety.
Check the product details to see if you have the recalled lot numbers. If you do, contact your pharmacy 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-0146-2026 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0146-2026 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.
