Lisdexamfetamine Dimesylate Capsules recall: Failed Dissolution
Lisdexamfetamine Dimesylate Capsules, 60 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 57664-051-88.
Why was Lisdexamfetamine Dimesylate Capsules recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: AD48711, Expiry: 4/30/2026; AD50896, Expiry: 5/31/2026.
- Product
- Lisdexamfetamine Dimesylate Capsules, 60 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 57664-051-88.
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Quantity
- N/A
- Distribution
- U.S Nationwide.
- Recall date
- November 5, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)