FDAHealthJune 16, 2025
SUN PHARMACEUTICAL INDUSTRIES INC — Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharma
⚠️ 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).
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 16, 2025
Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
What's affected?
- 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
- Lot code
- AD42648
Additional details
Lot # AD42648, Exp 02/28/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 5,448 bottles.
Get Health recall alerts
Delivered to your inbox. Free. No account required.