Class II
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
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).
- Recall number
- D-0516-2025
- Report date
- July 23, 2025
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Generic names
- LISDEXAMFETAMINE DIMESYLATE
- Brand names
- LISDEXAMFETAMINE DIMESYLATE
- Product NDCs
- 57664-046, 57664-047, 57664-048, 57664-049, 57664-050, 57664-051, 57664-052, 57664-083, 57664-084, 57664-085, 57664-086, 57664-087, 57664-088
Code and lot information
Lot # AD42648, Exp 02/28/2026
Distribution
Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.