Lisdexamfetamine 60 mg capsules recalled after failing dissolution at twelve month stability
Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 60 mg after an out-of-specification dissolution result at the 12-month stability station.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: Scored 2 as a specification failure: the record states only that dissolution specifications were not met, without describing a health consequence or reporting injury.
Plain-English summary
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, in 100-count bottles, manufactured by OHM Laboratories of New Brunswick, New Jersey and distributed by Sun Pharmaceutical Industries of Cranbury, New Jersey, are being recalled for failed dissolution specifications.
An out-of-specification result was observed in the dissolution test during analysis at the 12-month long term stability station.
The recall covers lots AD48711 (expiring 30 April 2026) and AD50896 (expiring 31 May 2026), carrying NDC 57664-051-88. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record states the dissolution failure without describing a health consequence, and reports no injuries. This is a prescription controlled substance, so patients holding an affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
- Brand
- LISDEXAMFETAMINE DIMESYLATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Stimulant
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.
Part of a larger recall action
This product is one of 7 recalled by SUN PHARMACEUTICAL INDUSTRIES INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
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