Drug recall D-0516-2025
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
Reason for recall
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).
Lots and codes
Lot # AD42648, Exp 02/28/2026
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 5,448 bottles
- Distribution
- Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 16, 2025
Related products
- Lisdexamfetamine dimesylate – drug information
- NDC 57664-086 Lisdexamfetamine Dimesylate · Lisdexamfetamine Dimesylate 40 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 57664-049 Lisdexamfetamine Dimesylate · Lisdexamfetamine Dimesylate 40 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 57664-088 Lisdexamfetamine Dimesylate · Lisdexamfetamine Dimesylate 60 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 57664-050 Lisdexamfetamine Dimesylate · Lisdexamfetamine Dimesylate 50 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 57664-046 Lisdexamfetamine Dimesylate · Lisdexamfetamine Dimesylate 10 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 57664-085 Lisdexamfetamine Dimesylate · Lisdexamfetamine Dimesylate 30 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 57664-048 Lisdexamfetamine Dimesylate · Lisdexamfetamine Dimesylate 30 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 57664-084 Lisdexamfetamine Dimesylate · Lisdexamfetamine Dimesylate 20 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 57664-051 Lisdexamfetamine Dimesylate · Lisdexamfetamine Dimesylate 60 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 57664-052 Lisdexamfetamine Dimesylate · Lisdexamfetamine Dimesylate 70 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 57664-047 Lisdexamfetamine Dimesylate · Lisdexamfetamine Dimesylate 20 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 57664-087 Lisdexamfetamine Dimesylate · Lisdexamfetamine Dimesylate 50 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 57664-083 Lisdexamfetamine Dimesylate · Lisdexamfetamine Dimesylate 10 mg/1 · Sun Pharmaceutical Industries, Inc.