Recall: D-0516-2025

Class II - Potentially Harmful

Class IIClassification

2025-06-16Initiated

OngoingStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

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

Reason

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).

Distribution

Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.