The UK-based healthcare company Haleon has issued a voluntary nationwide recall in the US of Robitussin cough syrups due to microbial contamination.
In a statement on Wednesday, Haleon recalled eight batches of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult, with expiration dates from October 2025 to June 2026.
It said it has not received any reports of adverse events related to the recall.
Robitussin is advertised as a product to sooth sore throats and alleviate cough and flu symptoms.
Haleon said immunocompromised individuals risked severe or life-threatening adverse events, such as fungemia – the presence of fungi or yeasts in the blood – should they use the products.
Symptoms of fungemia include chronic fatigue, severe confusion, non-healing and persistent lesions and wounds, unusual and irregular discharge, and sweating and itching.
The use of the products by immunocompromised individuals could also potentially lead to disseminated fungal infections, when a fungus spreads throughout the body, causing issues including skin ulcers, abscesses, fever, bone lesions or meningitis.
For non-immunocompromised individuals, life-threatening infections are unlikely, but Haleon said “the occurrence of an infection that may necessitate medical intervention cannot be completely ruled out”.
The company said that it is notifying its distributors and customers directly and has provided them with instructions for the return of all recalled products. Customers can contact Haleon’s consumer relations team at +1-800-245-1040 or by emailing mystory.us@haleon.com.
The company added that the recall is being conducted with the knowledge of the Food and Drug Administration.
Since January there have been at least four drug recalls in the US, including lubricant eye drops, various IV bags and Zenzedi or dextroamphetamine sulfate tablets, according to the FDA. Some of the reasons for the recalls were device and drug safety concerns, potential for super-potent drugs and mislabeled packaging.
