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FDARecalled Jul 23, 2025 · #D-0516-2025

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 085...

Hazard

Class II — temporary health risk

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Description

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). Classification: Class II Distribution: Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.

Product details

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
Type
Drugs
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Model numbers
AD42648
UPCs