Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0516-2025·Announced 2025-07-23

Lisdexamfetamine 60 mg capsules failed dissolution testing at nine month stability

Lisdexamfetamine Dimesylate Capsules 60 mg are being recalled because an out of specification result was observed in dissolution testing at the nine month long term stability station. 5,448 bottles affected.

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: FDA Class II recall for an out-of-specification dissolution result found in stability testing, with no health consequence stated in the source.

Plain-English summary

Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, prescription only, manufactured by OHM Laboratories of New Brunswick, New Jersey and distributed by Sun Pharmaceuticals, Inc. of Cranbury, New Jersey, NDC 57664-051-88, are being recalled. The action covers 5,448 bottles.

The stated reason is failed dissolution specifications: an out of specification result was observed in the dissolution test during analysis at the 9 month long term stability station at 25°C and 60% relative humidity. The FDA classified the action as Class II.

The affected lot is AD42648, expiring 02/28/2026. The recalled units were distributed to 17 distributors who may have further distributed them.

Patients holding the affected lot should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by the distributor.

The recalled product

Product: LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
Brand: LISDEXAMFETAMINE DIMESYLATE
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Category: Drug — Oral capsule
Hazard: dissolution-failure
stability-study
out-of-specification
class-ii
Affected units: 5,448

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 (2)

Lot # AD42648
Exp 02/28/2026

Distribution

Distributed nationwide across the United States.

Same brand · LISDEXAMFETAMINE DIMESYLATE

Moderate
Lisdexamfetamine capsules recalled after failing dissolution at twelve month stability
FDA (Drugs) · 2025-11-05
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Lisdexamfetamine 30 mg capsules recalled after failing dissolution at twelve month stability
FDA (Drugs) · 2025-11-05
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Lisdexamfetamine 70 mg capsules recalled after failing dissolution at twelve month stability
FDA (Drugs) · 2025-11-05
Moderate
Lisdexamfetamine 50 mg capsules recalled after failing dissolution at twelve month stability
FDA (Drugs) · 2025-11-05
Moderate
Lisdexamfetamine 10 mg capsules recalled after failing dissolution at twelve month stability
FDA (Drugs) · 2025-11-05

Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC

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