Lisdexamfetamine Dimesylate Capsules Recalled for Failed Dissolution Specifications
Sun Pharmaceutical recalls Lisdexamfetamine Dimesylate 30 mg capsules nationwide due to failed dissolution test results during 12-month stability testing. No illnesses have been reported.
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 FDA Class II recall addresses a pharmaceutical manufacturing quality defect (failed dissolution specifications) with no reported illnesses, injuries, or adverse events. The hazard is theoretical rather than demonstrated, consisting of potential loss of drug efficacy rather than direct health risk, qualifying as a precautionary recall.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling Lisdexamfetamine Dimesylate Capsules, 30 mg, distributed nationwide. The affected lot numbers are AD42470 (expiration 2/28/2026) and AD48708 (expiration 4/30/2026).
The product is being recalled because dissolution test results failed to meet specifications during 12-month long-term stability testing conducted at 25°C and 60% relative humidity. When a medication fails dissolution specifications, it may not dissolve and release properly in the body, potentially affecting how the drug works.
The FDA has classified this as a Class II recall. Consumers with affected products should consult with their pharmacist or healthcare provider to determine if they have recalled medication. Do not stop taking your medication without speaking to your healthcare provider first, as they can advise on alternative medications if needed.
No illnesses or injuries have been reported in connection with this recall.
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 #: AD42470
- Expiry: 2/28/2026
- AD48708
- Expiry:4/30/2026.
Distribution
Distributed nationwide across the United States.
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