Drug Recall: 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,
SUN PHARMACEUTICAL INDUSTRIES INC · June 16, 2025
Reason for Recall
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).
Product Description
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
Distribution
Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
States Affected
NATIONWIDE
Quantity Affected
5,448 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0516-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.