REGULATORY INTELLIGENCE·Recall
Sun Pharma Initiates Class II Recall of Lisdexamfetamine Dimesylate Capsules Due to Failed Dissolution Specifications
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.
90-Day Activity
LISDEXAMFETAMINE DIMESYLATELisdexamfetamine Dimesylate
MKMeera Krishnan· Senior Regulatory Intelligence Analyst2025-11-05