Drug Sold Nationwide Under Recall For Risk of “Life-Threatening Infections”

Bacterial infection is to blame for one in eight global deaths, making it the second leading cause of mortality after ischemic heart disease. Today, a major drug company has announced that one of their products designed to prevent infection is actually putting their patients at heightened risk.

On September 18, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of single-batch Atovaquone Oral Suspension, an antimicrobial drug used to prevent the fungal infection pneumocycstis jirovecii pneumonia (PCP) in adult and adolescent patients aged 13 and older. The product was determined to be contaminated with Cohnella bacteria.

This is particularly hazardous given that PCP infections most often occur in immunocompromised individuals, including those living with HIV/AIDS, chronic lung disease, autoimmune disease, cancer, and those taking medication that suppress the immune system, according to the Centers for Disease Control and Prevention (CDC). 

“In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as inflammation of the heart and permanent damage to soft tissue,” the company wrote in its recall announcement. At the time of publishing, BionPharma has not been notified that any consumers have experienced adverse effects.

The tainted product was shipped nationwide between December 21, 2023 and June 20, 2024 and distributed through wholesalers and retailers. The drug’s NDC number is 69452-252-87, and its lot number is 2310083. The drug, packaged in white 750-mg per mL (milligram per milliliter) bottles, is manufactured by CoreRx, Inc. in Clearwater, FL and distributed by BionPharma Inc.

Company leadership notes that they have implemented “enhanced quality control measures” with their manufacturer, CoreRx, to prevent future instances of contamination. “Our priority remains the safety and well-being of our consumers, and we are committed to transparency throughout this process,” they wrote in the recall announcement.

BionPharma is urging consumers who have received the affected lot of the product to immediately discontinue its use and return any remaining product to the place of purchase. Contact your healthcare provider if you believe you are experiencing an adverse reaction to use of the affected products.

Consumers affected by the recall can direct their questions to BionPharma by calling (888) 235-2466 (Mon-Fri 9AM-5PM EST) or via email at [email protected].

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