A drug got recalled after someone saw ‘black matter’ that can cause stroke or death

Little dark things shouldn’t be in vials of a drug, which is why one lot of an injection drug used to deal with low blood pressure under anesthesia got recalled.

Provepharm said it pulled lot No. 24020027 with December 2025 of Phenylephrine hydrochloride Injection, USP, 10 mg/mL after getting “a customer complaint from a pharmacy after observing a visible black particulate matter found in a single-sealed vial of the product.”

As the company’s FDA-posted recall notice explains, any such matter in an injection drug can be extremely problematic, well beyond just causing irritation or swelling around the injection site.

“If the particulate matter enters the blood vessels, it can travel to various organs and potentially block blood vessels in the heart, lungs or brain, leading to serious complications such as stroke or even death,” the statement said.

This drug is used to deal with the lowering of blood pressure under anesthesia.

Hospitals, pharmacies, wholesalers and anyone else with Phenylephrine from the recalled lot should stop using it and return it to Sedgwick, Event No. 8664, 2670 Executive Dr., Suite A, Indianapolis, IN 46241. For questions about returns, call Sedgwick at 866-737-5394 or email provepharm8664@sedgwick.com.

For medical questions, contact Provepharm at 833-727-6556 or safety-us@provepharm.com. If you suffer a medical problem, contact your medical professional first. Then, tell the FDA’s MedWatch Adverse Event Reporting Program, either online or by calling 800-332-1088 to request a reporting form.