Two varieties of Robitussin cough syrup have been recalled due to microbial contamination that could potentially cause severe or life-threatening events in immunocompromised people.
Haleon, the manufacturer of the medicine, issued a voluntary recall of eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult on Wednesday.
The affected products are labeled for the temporary relief of symptoms occurring with cold or flu, hay fever or other respiratory allergies and have expiration dates between May 2025 and June 2026.
To know the lot numbers of the affected products, you may check out the company announcement posted on the U.S. Food and Drug Administration (FDA) website.
"In immunocompromised individuals, the use of the affected product could potentially result in severe or life-threatening adverse events such as fungemia or disseminated fungal infection. In non-immunocompromised consumers, the population most likely to use the product, life-threatening infections are not likely to occur. However, the occurrence of an infection that may necessitate medical intervention cannot be completely ruled out," the announcement said.
The company confirmed that it has not received any reports of adverse events related to the recalled products. However, those who have purchased the affected products are being asked to stop consuming them immediately. Consumers should contact their physician or health care provider if they experience any problems linked to the use of the products.
The distributors have been notified and provided with instructions for the return of all recalled products.
"Consumer safety and product quality are our utmost priorities at Haleon. After a thorough investigation, a root cause has been identified and we are implementing corrective and preventative actions to ensure that this does not recur," the manufacturer said, according to ABC News.
As per the internal investigation by the company, the contamination was reportedly due to elevated levels of yeast. However, the manufacturer has not explained the exact cause behind the elevated levels.
Meanwhile, anyone who experiences adverse reactions or quality problems in relation to the affected products is encouraged to log a report via the FDA's MedWatch Adverse Event Reporting program. The issues can be reported online or by downloading the reporting form here and submitting the completed copy to the address. Reports can also be submitted through mail or fax to 1-800-FDA-0178.
