A single lot of Phenylephrine hydrochloride Injection, a medication crucial for managing dangerous blood pressure drops during anesthesia, is being recalled nationwide after the discovery of black particulate matter in a sealed vial, Provepharm Inc. announced.

The affected lot, number 24020027 with a December 2025 expiration date, was distributed to wholesalers across the U.S. The product is specifically identified by NDC code 81284-213-01 and is packaged in 10 mL single-dose vials.

"Administration of an injectable product containing particulate matter may cause local irritation or swelling as a response to the foreign material," Provepharm stated in their release. The company further warned that if particulates enter the bloodstream, they could potentially obstruct vessels in vital organs, "leading to serious complications such as stroke or even death."

The recall targets the hospital and institutional level, where the medication is primarily used to treat clinically significant hypotension resulting from vasodilation during anesthesia. To date, no adverse events or injuries related to this recall have been reported.

Healthcare facilities in possession of the affected lot are instructed to immediately discontinue use and coordinate returns through Sedgwick, Provepharm's recall management partner. Returns should be directed to Sedgwick's Indianapolis facility.

For medical inquiries, health care providers can contact Provepharm at 1-833-727-6556 or safety-us@provepharm.com. Product return logistics can be coordinated through Sedgwick's dedicated line at 866-737-5394.

The FDA has been notified of this voluntary recall, and adverse reactions may be reported through the FDA's MedWatch Adverse Event Reporting program. Health care providers should monitor patients who may have received medication from the affected lot for any adverse reactions or complications.