REGULATORY INTELLIGENCE·Recall
Huons Co., Ltd. Initiates Class II Recall for 7.1 Million Sodium Chloride Injection Ampules Over Sterility Concerns
Huons Co., Ltd. has initiated a Class II recall for 7,120,750 ampules of 0.9% Sodium Chloride Injection, USP, distributed nationwide in the USA. The recall, D-0531-2026, stems from a critical lack of assurance of sterility. This event necessitates immediate action from procurement and regulatory teams to mitigate supply chain disruptions and reassess supplier compliance.
90-Day Activity
Huons Co.,Water For Injection
MKMeera Krishnan· Senior Regulatory Intelligence Analyst2026-04-22 Recall