Lisdexamfetamine Dimesylate

Sun Pharmaceutical Industries, Inc. has initiated a U.S. Nationwide Class II recall for specific lots of Lisdexamfetamine Dimesylate Capsules, 20 mg, manufactured by OHM Laboratories. This action stems from failed dissolution specifications observed during stability testing, posing significant compliance and supply chain risks for procurement and regulatory teams managing Lisdexamfetamine Dimesylate sourcing.

Lannett Company, Inc. initiated a Class II recall for 8,544 bottles of Lisdexamfetamine Dimesylate Capsules due to a critical 40 mg/30 mg label mix-up. This event underscores the imperative for robust quality controls in pharmaceutical packaging. Procurement and regulatory teams must scrutinize supplier compliance to mitigate patient safety risks, supply chain disruptions, and potential for heightened FDA oversight following such fundamental errors.

Sun Pharmaceutical Industries Inc. has initiated a Class II recall (D-0516-2025) for 5,448 bottles of Lisdexamfetamine Dimesylate 60mg capsules due to failed dissolution specifications. This voluntary, firm-initiated action, stemming from 9-month stability testing, impacts nationwide distribution. Procurement and supply chain leaders must assess immediate inventory risks and re-evaluate Sun Pharma's recurring quality control challenges, demanding robust corrective actions to mitigate future supply disruptions and regulatory exposure.

Lannett Company, Inc. initiated a nationwide Class II recall for 1,608 bottles of Lisdexamfetamine Dimesylate Capsules (10 mg) due to failed content uniformity specifications. This FDA-terminated recall highlights critical quality control issues for procurement directors and regulatory affairs heads, necessitating immediate supply chain review and enhanced supplier due diligence for Lannett's products.