Lisdexamfetamine Dimesylate Capsules Recalled Due to Failed Dissolution Specifications
Sun Pharmaceutical is recalling Lisdexamfetamine Dimesylate 60 mg capsules (Lots AD48711 and AD50896) distributed nationwide due to failed dissolution specifications identified in stability testing. The affected capsules may not dissolve properly.
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 is an FDA Class II recall for failed dissolution specifications that could impair drug bioavailability. Dissolution failure represents a risk-of-harm scenario for a controlled substance where therapeutic efficacy depends on proper formulation, meeting the High severity threshold per the rubric.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling Lisdexamfetamine Dimesylate Capsules, 60 mg, distributed nationwide. The recall affects two specific lots: AD48711 (expiration 4/30/2026) and AD50896 (expiration 5/31/2026).
The FDA Class II recall was issued due to failed dissolution specifications identified during 12-month long-term stability testing conducted at 25°C and 60% relative humidity. Dissolution testing is a quality control measure that ensures capsules properly dissolve so the medication can be absorbed. When dissolution specifications fail, the medication may not dissolve as intended, which could affect drug delivery and therapeutic efficacy.
Patients currently taking Lisdexamfetamine Dimesylate from the affected lots should not stop taking their medication without consulting their healthcare provider. Anyone with questions or concerns about their medication should speak with their pharmacist or physician. Healthcare providers and pharmacists should check their inventory for the affected lot numbers.
The recalled product
- Product
- LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
- Brand
- LISDEXAMFETAMINE DIMESYLATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- Hazard
- dissolution-failure
- bioavailability-loss
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 #: AD48711
- Expiry: 4/30/2026
- AD50896
- Expiry: 5/31/2026.
Distribution
Distributed nationwide across the United States.
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