Sun Pharmaceutical recalls 20mg Lisdexamfetamine Dimesylate capsules with failed dissolution tests. These prescription-only capsules may not release medication properly.
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 prescription lisdexamfetamine capsules that failed dissolution tests during stability testing. This means the capsules might not release medication as intended, potentially affecting treatment effectiveness.
The capsules failed dissolution tests during long-term stability testing at 25°C and 60% humidity. This suggests the medication may not release properly in the body, potentially reducing effectiveness but not causing immediate harm.
Prescription patients who have the specific lot numbers of lisdexamfetamine capsules. Those with the 20mg strength, 100-count bottles, and Rx-only status are most affected.
Check for the lot numbers AD42469 (expires 2/28/2026) or AD48707 (expires 4/30/2026) on the packaging. The product is a prescription-only 20mg lisdexamfetamine capsule bottle with NDC 57664-047-88.
Look for lot numbers AD42469 or AD48707 on the packaging of the 20mg lisdexamfetamine capsules.
The capsules failed dissolution tests during long-term stability testing at 25°C and 60% humidity, which may affect medication release.
Check the lot number on the packaging. If it's AD42469 or AD48707, contact your pharmacy for guidance.
The recall is for potential reduced effectiveness, not a risk of serious injury. The danger level is low risk.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0145-2026 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0145-2026 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.
