Class II
Ongoing
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
This recall is currently active, issued July 23, 2025. It was issued by Sun Pharmaceutical Industries Inc.
- Recall Initiated
- June 16, 2025
- Posted
- July 23, 2025
- Recall Number
- D-0516-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5,448 bottles
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
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).
Distribution
Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
Lot / Code Info
Lot # AD42648, Exp 02/28/2026
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