Haloperidol Decanoate

BluePoint Laboratories faces an FDA Class II recall of 14,189 vials of Haloperidol Decanoate Injection, 100 mg/mL, due to bacterial contamination from its manufacturer, Somerset Therapeutics Limited in India. This nationwide recall, D-0368-2025, demands immediate action from procurement and regulatory teams to secure alternative supplies and assess supply chain vulnerabilities for this critical Central Nervous System drug.

Somerset Therapeutics, LLC faces significant regulatory scrutiny following a Class II recall of Haloperidol Decanoate Injection due to sterility assurance failures. This voluntary, firm-initiated recall of 240 vials distributed U.S. nationwide highlights critical manufacturing control deficiencies at its Bengaluru, India facility. Procurement and regulatory teams must assess supply chain risks and prepare for potential market disruptions for this antipsychotic medication.

Somerset Therapeutics, LLC has initiated a Class II recall for Haloperidol Decanoate Injection due to water contamination in an oil-based product. This nationwide U.S. recall, affecting 5,578 units, underscores critical supply chain and quality control vulnerabilities for procurement directors and regulatory affairs heads. Proactive risk mitigation and enhanced supplier oversight are immediately required.