Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM...
FDA Recall #D-0147-2026 — Class II — October 28, 2025
Product Description
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.
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.
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
U.S Nationwide.
Code Information
Lot #: AD48709, Expiry: 4/30/2026; AD50894, Expiry: 5/31/2026.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated