June 2025 FDA Recall Lisdexamfetamine Dimesylate by Sun Pharmaceutical Industries Inc
D-0516-2025 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on June 16, 2025 for the product Lisdexamfetamine Dimesylate. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0516-2025
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).
06-16-2025
07-23-2025
5,448 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# AD42648, Exp 02/28/2026
