Prescription Lisdexamfetamine Dimesylate Capsules Recalled for Failed Dissolution Testing
Sun Pharmaceutical Industries is recalling specific lots of Lisdexamfetamine Dimesylate capsules because they failed dissolution testing during stability analysis. The affected lots may not dissolve properly to deliver the intended dose.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a prescription drug with failed dissolution specifications and no reported illnesses or adverse events. Per the severity rubric, risk-of-harm products with no reported injury are scored at the High level.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling specific lots of Lisdexamfetamine Dimesylate capsules (10 mg, prescription strength) manufactured by OHM Laboratories. During 12-month stability testing conducted at controlled conditions (25°C, 60% relative humidity), out-of-specification results were observed in dissolution testing, indicating the medication may not dissolve and release properly to provide the intended dose.
The recall affects Lisdexamfetamine Dimesylate Capsules, 10 mg, lot numbers AD42468 (expiration 2/28/2026) and AD48705 (expiration 4/30/2026), distributed nationwide in the United States under NDC 57664-046-88.
No illnesses or adverse events have been reported associated with these lots. Patients currently taking the recalled medication should contact their pharmacy or healthcare provider for further guidance. Healthcare providers and pharmacies should check their inventory for affected lot numbers and contact patients who may have received the recalled product.
The recalled product
- Product
- LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
- Brand
- LISDEXAMFETAMINE DIMESYLATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Prescription
- Hazard
- dissolution-failure
- reduced-efficacy
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 #: AD42468
- Expiry: 2/28/2026
- AD48705
- Expiry: 4/30/2026.
Distribution
Distributed nationwide across the United States.
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