Sun Pharmaceutical recalls 50mg Lisdexamfetamine Dimesylate capsules due to failed dissolution tests at 12 months. This may affect medication reliability. Check NDC 57664-050-88 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 50mg Lisdexamfetamine Dimesylate capsules that failed dissolution tests after 12 months of storage. This could mean the medication doesn't work as intended, so affected users should check their product details and contact the manufacturer.
The capsules failed dissolution tests after 12 months of storage under controlled conditions. This suggests the medication might not release properly in the body, potentially affecting its effectiveness. However, the recall does not indicate a safety risk to users.
People with prescriptions for Lisdexamfetamine Dimesylate 50mg capsules from Sun Pharmaceutical. Those who have the specific NDC 57664-050-88 lot numbers are most at risk.
Check for the NDC code 57664-050-88 on the product label. Look for lot numbers AD48710 (expiry 4/30/2026) or AD50895 (expiry 5/31/2026).
Look for the NDC code 57664-050-88 and lot numbers AD48710 or AD50895 on the capsule packaging.
The recall indicates the capsules failed dissolution tests after 12 months, but the manufacturer does not state this poses a safety risk. The product may not work as intended.
Check for the NDC code 57664-050-88 and lot numbers AD48710 (expiry 4/30/2026) or AD50895 (expiry 5/31/2026).
The recall does not specify a remedy, so contact Sun Pharmaceutical directly 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-0148-2026 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0148-2026 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.
