⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

SUN PHARMACEUTICAL INDUSTRIES INC: Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Dis

DrugsSource: FDA (drug) · Date: 2025-11-05

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
SUN PHARMACEUTICAL INDUSTRIES INC
Product
Lisdexamfetamine Dimesylate Capsules, 50 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 57664-050-88.
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S Nationwide.
Recall initiated
2025-10-28
Code info
Lot #:AD48710, Expiry: 4/30/2026; AD50895, Expiry: 5/31/2026.
Product quantity
N/A
Voluntary mandated
Voluntary: Firm initiated
City
Princeton
State
NJ
Country
United States
Event id
97874
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