Injectable Phenylephrine Recalled Due to Particulate Contamination Risk

Provepharm, Inc has issued a voluntary recall of Phenylephrine HCl Injection USP, 100 mg/10 mL (10 mg/mL) vials due to the presence of particulate matter in the product. The affected lot #24020027 (expiration date 12/31/25) includes 24 640 vials distributed nationwide in the US. The recall was initiated on January 21, 2025, with notification to consignees via letter, and remains ongoing as of the latest US Food and Drug Administration (FDA) Enforcement Report update.

The FDA has classified this as a Class I recall, indicating a high risk of severe injury or death if the affected product is administered. Injectable medications contaminated with particulate matter can pose serious health risks, including vascular blockages, embolism, and organ damage. Provepharm, Inc based in Collegeville, Pennsylvania, is actively working with the FDA to remove the affected vials from circulation. Pharmacists should immediately check inventory, quarantine the recalled lot, and follow the firm's instructions for return and disposal.

Phenylephrine HCl Injection is a vasopressor used in hospital and clinical settings to treat hypotension (low blood pressure), particularly during anesthesia. It works by constricting blood vessels, increasing blood pressure, and improving perfusion to vital organs. Due to its critical role in managing hypotension, alternative supplies should be secured to prevent disruptions in patient care. Pharmacists should ensure affected vials are not dispensed or used and report any adverse reactions to the FDA MedWatch program.