D-0145-2026Class II

SUN PHARMACEUTICAL INDUSTRIES INC

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2025-11-05

Distribution

U.S Nationwide.

Firm state

Product quantity

N/A

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Validation & Qualification

Reason for recall

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.

Product description

Lisdexamfetamine Dimesylate Capsules, 20 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 57664-047-88.

Code / lot info

Lot #: AD42469, Expiry: 2/28/2026; AD48707, Expiry:4/30/2026.

Other recalls SPEQ maps to Validation & Qualification

2026-07-22Class IIBell Pharmaceuticals, Inc 2026-07-22Class IIBell Pharmaceuticals, Inc 2026-07-22Class IIBell Pharmaceuticals, Inc 2026-07-22Class IIBell Pharmaceuticals, Inc

See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.