FDA Drugs recall ·
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles… recall
- Recall number
- D-0516-2025
- Date
- (initiated June 16, 2025)
- Company / brand
- Sun Pharmaceutical Industries Inc
2 Independence Way, Princeton, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5,448 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
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).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # AD42648, Exp 02/28/2026
Distribution
Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0516-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.