The recalled product, identified as Lot #25202 (NDC 0517-4002-25), has been in circulation since September 30, 2025, and carries an expiration date of November 30, 2026. While the company reports no adverse events linked to the batch to date, the presence of foreign matter in an injectable medication presents a severe threat. If administered, these particles can cause local irritation or travel through the bloodstream, potentially blocking vessels in the heart, lungs, or brain, which may lead to stroke or fatality.

Healthcare facilities and patients are instructed to immediately cease use of the affected vials. Distributors are currently being notified to facilitate returns and replacements. Those holding the product should contact their physician or return the medication to the point of purchase. For further guidance, American Regent maintains dedicated channels for quality complaints and medical inquiries at 888-354-4855, while reports of adverse reactions can also be directed to the FDA’s MedWatch program.