LISDEXAMFETAMINE DIMESYLATE
Recalling Firm / Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
(Princeton, NJ, United States)
FDA Recall Number: D-0516-2025
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
LISDEXAMFETAMINE DIMESYLATE
Generic Name
LISDEXAMFETAMINE DIMESYLATE
Active Substance(s)
Lisdexamfetamine Dimesylate
Administration Route
Oral
National Drug Code (NDC)
57664-046
Total Quantity Recalled
5,448 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
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).
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
July 23, 2025
Firm Initiation Date
June 16, 2025
FDA Classification Date
Jul 11, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot # AD42648, Exp 02/28/2026
Distribution Information
Geographic scope of affected shipments
Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0516-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508615UTCC