Prescription Lisdexamfetamine Dimesylate Capsules Recalled Due to Failed Dissolution Specifications
Sun Pharmaceutical is recalling specific lots of Lisdexamfetamine Dimesylate capsules nationwide because dissolution test results fell outside specifications during stability testing.
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 or injuries. The recall addresses a quality/dissolution specification failure detected during routine stability testing, which constitutes a voluntary precautionary measure rather than a response to confirmed harm.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling specific lots of Lisdexamfetamine Dimesylate Capsules, 40 mg (Rx only, CII), distributed nationwide. The affected lots are: Lot AD48709 (expiration 4/30/2026) and Lot AD50894 (expiration 5/31/2026).
The recall was initiated because dissolution test results fell outside specifications during 12-month long-term stability testing. Dissolution specifications are critical quality standards that ensure the medication dissolves properly and delivers the intended dose.
Patients currently taking this medication should contact their pharmacist or physician for guidance. Do not discontinue use without medical advice. Pharmacies should quarantine affected lots and contact patients who received them. The FDA is monitoring 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 #: AD48709
- Expiry: 4/30/2026
- AD50894
- Expiry: 5/31/2026.
Distribution
Distributed nationwide across the United States.
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