Prescription Lisdexamfetamine Dimesylate Capsules Recalled for Failed Dissolution Test Results
Sun Pharmaceutical is recalling specific lots of Lisdexamfetamine Dimesylate 70 mg capsules nationwide due to failed dissolution test results detected 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: FDA Class II classification with no reported illnesses or injuries. The dissolution test failure was detected during stability testing before product distribution. This is a voluntary precautionary recall of a manufacturing quality control issue.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling specific lots of Lisdexamfetamine Dimesylate 70 mg capsules due to failed dissolution specifications discovered during stability testing. The product did not meet dissolution standards during 12-month stability testing at 25°C and 60% relative humidity.
The affected product lots are Lot #AD48712 (expiring 4/30/2026) and Lot #AD50898 (expiring 5/31/2026). Distribution was nationwide in the United States. No illnesses or injuries have been reported related to this recall.
Patients taking this medication should verify their lot number on the prescription bottle label. Those with an affected lot number should contact their pharmacist or healthcare provider. The product was manufactured by OHM Laboratories and distributed by Sun Pharmaceutical Industries Inc.
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 #: AD48712
- Expiry: 4/30/2026
- AD50898
- Expiry: 5/31/2026.
Distribution
Distributed nationwide across the United States.
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