FDAFDA · Food and drugs·Recall number D-0144-2026
Lisdexamfetamine Dimesylate Capsules, 10 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 57664-046-88.
Published November 5, 2025 · Recall initiated: October 28, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LISDEXAMFETAMINE DIMESYLATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- U.S Nationwide.
- Lot
- Lot #: AD42468, Expiry: 2/28/2026; AD48705, Expiry: 4/30/2026.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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