Drug recall D-0149-2026
Product
Lisdexamfetamine Dimesylate Capsules, 60 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 57664-051-88.
Reason for recall
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.
Lots and codes
Lot #: AD48711, Expiry: 4/30/2026; AD50896, Expiry: 5/31/2026.
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- N/A
- Distribution
- U.S Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 28, 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.