Prescription drug Lisdexamfetamine recall due to failed dissolution specifications
Sun Pharmaceutical Industries is recalling Lisdexamfetamine Dimesylate capsules nationwide due to failed dissolution specifications discovered during 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 is an FDA Class II recall based on failed dissolution specifications discovered during stability testing. No illnesses or adverse events have been reported. The recall is precautionary and proactive in nature, based on a quality defect affecting drug efficacy rather than an acute safety hazard.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling Lisdexamfetamine Dimesylate Capsules, 20 mg, in 100-count bottles distributed nationwide. The recall was issued because certain lots failed dissolution specifications during stability testing. When a capsule fails to dissolve properly, the medication may not be absorbed effectively.
Affected lots include Lot #AD42469 (Expiry 2/28/2026) and Lot #AD48707 (Expiry 4/30/2026). Lisdexamfetamine Dimesylate is a prescription controlled substance (Schedule II) used to treat ADHD. No illnesses or adverse events have been reported in connection with this recall.
Patients taking Lisdexamfetamine Dimesylate should contact their healthcare provider or pharmacist immediately if they believe they have received an affected lot. Do not discontinue the medication without consulting a doctor. Return any affected product to the pharmacy where it was obtained.
The recalled product
- Product
- LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
- Brand
- LISDEXAMFETAMINE DIMESYLATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — ADHD Stimulant
- Hazard
- failed-dissolution
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 #: AD42469
- Expiry: 2/28/2026
- AD48707
- Expiry:4/30/2026.
Distribution
Distributed nationwide across the United States.
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