FDAHealthOctober 28, 2025
SUN PHARMACEUTICAL INDUSTRIES INC — Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmac
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 28, 2025
U.S Nationwide.
What's affected?
- Product
- Lisdexamfetamine Dimesylate Capsules, 50 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 57664-050-88.
- Lot code
- AD48710
Additional details
Lot #:AD48710, Expiry: 4/30/2026; AD50895, Expiry: 5/31/2026.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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