Nationwide recall issued for injectable drug after glass, paraformaldehyde detected Published: Jul. 28, 2026, 9:00 a.m. FDA The FDA warns patients using the contaminated injectable may experience blood vessel blockages, stroke or even death.(AP Photo/Manuel Balce Ceneta) By Dallas Gagnon | MassLive.com A drug used to treat poor blood circulation, muscle spasms and erectile dysfunction is being recalled after the drug maker, American Regent, Inc., found foreign matter floating in the solution. According to the Food and Drug Administration, the material was identified as glass and/or paraformaldehyde, a compound related to formaldehyde. The FDA issued a recall of one lot of Papaverine Hydrochloride Injection on July 24, citing risks of “local irritation or swelling” and blocked blood vessels that could lead to stroke or death. “The particulate matter could travel through and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death,” the FDA warns. Patients with underlying cardiovascular or pulmonary conditions may be at increased risk, the agency said. “To date, American Regent, Inc. has not received any reports of adverse events related to this recall.” According to the FDA, papaverine is a prescription medication that relaxes smooth muscles and widens blood vessels, primarily used to treat visceral spasms, poor blood circulation and erectile dysfunction. The affected product, a 60 mg/2 mL single-dose vial, carries lot number 25202 and NDC 0517-4002-25, with an expiration date of Nov. 30, 2026. Products were distributed nationwide beginning Sept. 30, 2025. The FDA urges consumers and health care providers to immediately stop using the recalled product and return it to the place of purchase, or discard it, and contact a doctor with any related concerns.