Lisdexamfetamine Dimesylate Capsules Recalled Due to Dissolution Specification Failure
Sun Pharmaceutical is recalling 5,448 bottles of Lisdexamfetamine Dimesylate 60mg capsules due to failed dissolution specifications detected during long-term stability testing. No illnesses have been reported.
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: This FDA Class II recall involves a prescription medication where dissolution specification failure could affect medication effectiveness or absorption. Although no illnesses or injuries have been reported, the defect was detected during stability testing. This constitutes a risk-of-harm product classification without yet-reported injury, meeting the rubric criterion for High severity.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling 5,448 bottles of Lisdexamfetamine Dimesylate 60mg capsules (Lot AD42648, expiring 02/28/2026) due to failed dissolution specifications. The issue was identified during long-term stability testing conducted at 25°C and 60% relative humidity at the 9-month testing point.
Dissolution specifications are critical quality measures that ensure a medication releases its active ingredient at the proper rate for absorption by the body. When a medication fails dissolution testing, the active ingredient may not be absorbed as intended, potentially affecting its effectiveness.
The recalled bottles were distributed to 17 wholesale distributors, who may have further distributed the product nationwide.
The recalled product
- Product
- LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
- Brand
- LISDEXAMFETAMINE DIMESYLATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Prescription Medication
- Hazard
- dissolution-failure
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.
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