[pending] LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
Pending LLM rewrite. Source: FDA_DRUG D-0516-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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).
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 (2)
- Lot # AD42648
- Exp 02/28/2026
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · LISDEXAMFETAMINE DIMESYLATE
- HighPrescription Drug Lisdexamfetamine Dimesylate Recalled for Failed Content Uniformity
FDA (Drugs) · 2024-12-11
Same category
- ModerateQuality Choice Earwax Removal Kit Carbamide Peroxide Subpotent Drug Recall
FDA (Drugs) · 2026-07-22
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateClinere Ear Wax Remover Recalled for Subpotent Carbamide Peroxide
FDA (Drugs) · 2026-07-22