FDAFDA · Food and drugs·Recall number D-0516-2025
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
Published July 23, 2025 · Recall initiated: June 16, 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 9 month long term stability station (25¿C, 60%RH).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LISDEXAMFETAMINE DIMESYLATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
- Lot
- Lot # AD42648, Exp 02/28/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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