SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Bru…

Recall date

October 28, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0147-2026

FDA classification

Class II

Brand / firm

SUN PHARMACEUTICAL INDUSTRIES INC

Sold / distributed

U.S Nationwide.

Why it was recalled

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-049-88.