Class II
Lisdexamfetamine Dimesylate Capsules, 40 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 57664-049-88.
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.
- Recall number
- D-0147-2026
- Report date
- November 5, 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 #: AD48709, Expiry: 4/30/2026; AD50894, Expiry: 5/31/2026.
Distribution
U.S 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.