Lisdexamfetamine Dimesylate Capsules Recalled for Failed Dissolution Specifications
Sun Pharmaceutical is recalling specific lots of Lisdexamfetamine Dimesylate Capsules 50 mg due to failed dissolution specifications that may affect medication effectiveness.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is a manufacturing quality issue (failed dissolution specifications) affecting drug efficacy. Per the rubric, recalls with theoretical hazards and no reported adverse events score at most 3; this quality control matter appropriately scores as Moderate.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling Lisdexamfetamine Dimesylate Capsules, 50 mg, distributed nationwide in the United States.
The recall was initiated due to failed dissolution specifications discovered during long-term stability testing. During stability analysis at 12 months, testing revealed out-of-specification results in dissolution testing. Dissolution specifications relate to how the medication dissolves in the body, and failure to meet these specifications may affect the medication's effectiveness.
The affected lots are AD48710 (expires 4/30/2026) and AD50895 (expires 5/31/2026). This is a Class II recall issued by the FDA.
The recalled product
- Product
- LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
- Brand
- LISDEXAMFETAMINE DIMESYLATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- 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 (4)
- Lot #:AD48710
- Expiry: 4/30/2026
- AD50895
- Expiry: 5/31/2026.
Distribution
Distributed nationwide across the United States.
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