The Recall Desk
ModerateFDA (Drugs)·D-0148-2026·Announced 2025-11-05

Lisdexamfetamine 50 mg capsules recalled after failing dissolution at twelve month stability

Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 50 mg after an out-of-specification dissolution result at the 12-month stability station.

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: 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, 50 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 AD48710 (expiring 30 April 2026) and AD50895 (expiring 31 May 2026), carrying NDC 57664-050-88. 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
Hazard

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 #:AD48710
  • Expiry: 4/30/2026
  • AD50895
  • 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

Same brand · LISDEXAMFETAMINE DIMESYLATE

Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC

See all →

Same hazard · failed dissolution

See all →