Sun Pharmaceuticals recalls 60mg lisdexamfetamine capsules (NDC 57664-051-88) due to failed dissolution tests at 9 months. This may affect drug stability and safety.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
Sun Pharmaceuticals is recalling 60mg lisdexamfetamine dimesylate capsules (100-count bottles) because lab tests showed the medication didn't dissolve properly after 9 months. This could mean the drug isn't working as intended or may be unsafe for patients.
The capsules failed dissolution tests after 9 months of storage at 25°C and 60% humidity. This means the medication might not release the active ingredient properly when taken, potentially affecting its effectiveness or safety.
People with prescriptions for lisdexamfetamine dimesylate capsules (60mg, 100-count bottles) from Sun Pharmaceuticals. Those who have the specific lot number AD42648 are most at risk.
Check for the product name 'Lisdexamfetamine Dimesylate Capsules, 60 mg', 100-count bottles, and lot number AD42648. The expiration date is February 28, 2026.
Look for the lot number AD42648 on the packaging to confirm if your product is affected.
The recall is due to failed dissolution tests, which may affect the medication's effectiveness or safety. Consult your healthcare provider for advice.
Check the lot number on the packaging. If it's AD42648, contact Sun Pharmaceuticals for instructions.
Look for the lot number AD42648 on the packaging. The product was manufactured by OHM Laboratories in New Brunswick, NJ.
We’ve drafted a message you can send Sun Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0516-2025 — Sun Pharmaceuticals Sun Pharmaceuticals Hello, I own a Sun Pharmaceuticals that is covered by recall D-0516-2025 from Sun Pharmaceuticals. 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.
