Class IIOngoing

Lisdexamfetamine Dimesylate Capsules recall

FDA recall D-0516-2025 · initiated Jun 16, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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).

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
Recalling company: Sun Pharm Industries
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
Initiated: Jun 16, 2025
FDA report date: Jul 23, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0516-2025 ↗

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