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Recall Observatory FDA recall evidence

Drug 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

D-0516-2025

June 16, 2025

Class II

Product summary

Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Event
Event 97092
Status
Ongoing
Classification
Class II
Quantity
5,448 bottles
Official record key
drug-enforcement:D-0516-2025

Official wording

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).

Code information: Lot # AD42648, Exp 02/28/2026

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

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification