The U.S.-based unit of the company, which is located in the UK, warned that contamination from the impacted products could lead to severe or life-threatening adverse events in some individuals with underlying health conditions.
However, it noted there have been no reports of adverse events related to the recall so far.
Approximately eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult cough syrups are being recalled.
They include six lots of Robitussin Honey CF Max Day Adult, four-ounce and eight-ounce, and two lots of Robitussin Honey CF Max Adult, in eight-ounce.
The Robitussin Honey CF Max Day Adult four-ounce subject to the recall has a lot number of T10810 and expires on Oct 31, 2025.
Five lots of daytime cough syrups in eight-ounce that were recalled have the lot numbers T08730, T08731, T08732, and T08733, all of which expire on May 31, 2025. The sixth lot of daytime cough syrups in eight-ounce subject to the recall has a lot number of T10808 and expires on Sept. 30, 2025.
The two lots of nighttime cough syrup that are being recalled have the lot numbers T08740 and T08742. Both expire on June 30, 2026.
The cough syrups subject to the recall are indicated for the temporary relief of symptoms occurring with cold or flu, hay fever, or other respiratory allergies, Haleon said.
Immunocompromised Individuals May Be at Risk
The products have likely seen an uptick in sales amid a surge in respiratory syncytial virus (RSV) cases, some of which health officials say have resulted in the deaths of children.Haleon said it is notifying its distributors and customers directly about the recalled items and has provided them with instructions on how to return the products.
The company is also warning consumers who may have purchased the impacted products to stop using them immediately.
According to the FDA, immunocompromised individuals who use the products impacted by the recall could potentially suffer severe or life-threatening adverse events such as fungemia or disseminated fungal infection.
Fungemia is the presence of fungi or yeasts in the blood. The most common type of fungemia is candida, also known as candidemia, according to the Centers for Disease Control and Prevention.
In the United States, candida is one of the most common causes of bloodstream infections in hospitalized patients and can often result in patients being hospitalized for long periods of time, or in worse cases, death, according to the health agency.
It is often resistant to antifungal treatments and impacts individuals with severe underlying medical conditions. Symptoms of bacterial infections include fever, chills, tiredness, and headaches, according to the Cleveland Clinic. In worse cases, symptoms can develop into shortness of breath, chest pain, low blood pressure, and confusion.
The FDA noted that in non-immunocompromised consumers using the recalled products, life-threatening infections are not likely to occur. However, the agency noted the occurrence of an infection that may necessitate medical intervention “cannot be completely ruled out.”
Haleon and the FDA urged consumers to contact their physician or health care provider if they have experienced any problems that may be related to taking or using the product.
