SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Br…

Recall date

June 16, 2025

Source

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

Recall number

D-0516-2025

FDA classification

Class II

Brand / firm

SUN PHARMACEUTICAL INDUSTRIES INC

Sold / distributed

Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.

Why it was recalled

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).

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, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88