Class II
Ongoing
Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-047-88.
This recall is currently active, issued November 5, 2025. It was issued by Sun Pharmaceutical Industries Inc.
- Recall Initiated
- October 28, 2025
- Posted
- November 5, 2025
- Recall Number
- D-0145-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- 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 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Distribution
U.S Nationwide.
Lot / Code Info
Lot #: AD42469, Expiry: 2/28/2026; AD48707, Expiry:4/30/2026.
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