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
Reported: July 23, 2025 Initiated: June 16, 2025 #D-0516-2025
Product Description
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).
Details
- Recalling Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Units Affected
- 5,448 bottles
- Distribution
- Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 5,448 bottles.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 23, 2025. Severity: Moderate. Recall number: D-0516-2025.
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