Major New Recall of Robitussin Cough Syrup for "Contamination," FDA Warns
Eight lots were pulled after it was found the medication could put people at risk for infections.
As a kid, you might have dreaded taking Robitussin, which didn't necessarily have the most appealing taste. Even so, there was no denying its effectiveness when treating a cough, and it's still something most of us keep around the house during cold and flu season. But while Robitussin remains one of the most trusted names in over-the-counter medication, you'll want to double-check the bottle you have in your medicine cabinet, thanks to a new recall.
In a Jan. 24 alert from the U.S. Food and Drug Administration (FDA), consumer health company Haleon announced that eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult have been recalled. Both are used to treat symptoms related to cold or flu, hay fever, and other respiratory allergies, according to the FDA. On the medications' packaging, it specifically notes cough control and relief from a runny nose, sneezing, fever, and body aches.
Per the FDA alert, the Robitussin products were recalled due to "microbial contamination." For those who are immunocompromised, using these Robitussin products "could potentially result in severe or life-threatening adverse events such as fungemia or disseminated fungal infection," the agency says.
According to the National Library of Medicine, fungemia is the presence of fungus in the blood. The most common type is candidemia, which can result results in "long hospital stays and death," per the Centers for Disease Control and Prevention (CDC).
For those who aren't immunocompromised, which the agency cites as "the population most likely to use the product," the recalled Robitussin isn't likely to cause a life-threatening infection. However, these individuals could still develop an infection that requires medical intervention.
Robitussin Honey CF Max Day liquids were sold in four-ounce and eight-ounce bottles, with expiration dates between May 31, 2025, and Sept. 30, 2025. The nighttime version was sold in eight-ounce bottles, which have an expiration date of June 30, 2026. A complete list of lot numbers and specific expiration dates is included in the FDA alert. On the Robitussin bottles, both the lot code and expiration date are printed on the back label, in the bottom right-hand corner.
If you have recalled Robitussin products at home, the FDA asks that you "stop consumption immediately" and contact your healthcare provider if you experience any problems related to the medication. Haleon hadn't received any reports of adverse events related to the product as of Jan. 24.
The company is notifying both distributors and customers directly about the recall and including instructions to return affected products, the FDA notice states. Consumers can also call Haleon's customer relations team at 1-800-245-1040, Monday through Friday between 8 a.m. and 6 p.m. Eastern Time (ET), or email [email protected] with direct questions.
Additionally, the FDA asks that you report quality problems or adverse events to its MedWatch Adverse Event Reporting Program. You can do so by completing a form online, or via regular mail or fax. Download the form online or call 1-800-332-1088 to request a reporting form.
- Source: FDA: Haleon Issues Voluntary Nationwide Recall of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult Products Due to Microbial Contamination
- Source: National Library of Medicine: Fungemia Candidiasis
- Source: CDC: About Invasive Candidiasis
- Source: Reporting Serious Problems to FDA
- Source: MedWatch Forms for FDA Safety Reporting