CAPS Recalls Phenylephrine IV Bags Due to Black Particulate Matter: What You Need to Know

 

CAPS Recalls Phenylephrine IV Bags Due to Black Particulate Matter: What You Need to Know

Published: March 03, 2025
By: Garcia Family Medicine Team

On February 24, 2025, Central Admixture Pharmacy Services (CAPS) announced a nationwide recall of three lots of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL IV bags due to visible black particulate matter found in a supplier’s vial. At Garcia Family Medicine, we’re here to unpack this recall and its potential impact on your health.

The Recall

CAPS is pulling these IV bags (NDC: 71285-6092-1) from hospitals after their supplier detected contamination in a single sealed vial of Phenylephrine Hydrochloride. The affected lots—37-928390 (exp. 03MAR2025), 37-928796 (exp. 09MAR2025), and 37-928839 (exp. 10MAR2025)—were distributed across the U.S. between December 17, 2024, and January 8, 2025. This recall targets hospital-level use, not consumer products like vapes or oral medications.

Health Risks

Injecting a product with particulate matter could lead to serious issues. Locally, it might cause irritation or swelling. If particles enter the bloodstream, they could block vessels in the heart, lungs, or brain, potentially triggering strokes or even death. Thankfully, CAPS reports no adverse events so far, but the risk is real—something we monitor closely in our practice.

What’s Happening Now

CAPS is notifying hospitals and distributors via certified mail to arrange returns. The FDA is overseeing the recall, and consumers can report issues to the FDA’s MedWatch program (online at www.fda.gov/medwatch/report.htm or by calling 1-800-332-1088). If you’re a patient who’s received IV treatment recently, consult your healthcare provider about any concerns.

Our Support

At Garcia Family Medicine, we’re committed to your safety. If you or a loved one uses IV therapies—or if you’re worried about past treatments—contact Dr. Tess Garcia at +1 (816) 427-5320 or email drtess@gmfdpc.com. We can assess your situation and offer personalized guidance, especially for those with chronic conditions requiring IV medications.

Stay proactive about your health,
Garcia Family Medicine Team

For more, visit us at garciafamilymedicine.care.

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