LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
Pending LLM rewrite. Source: FDA_DRUG D-0144-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
- Brand
- LISDEXAMFETAMINE DIMESYLATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: AD42468
- Expiry: 2/28/2026
- AD48705
- Expiry: 4/30/2026.
Distribution
Distributed nationwide across the United States.
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