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Haleon Issues Voluntary Nationwide Recall of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult Products Due to Microbial Contamination

Audience: Consumers

January 24, 2024 – Warren, NJ, Haleon is voluntarily recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult to the consumer level. The product is being recalled due to microbial contamination.

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.

To date, Haleon has not received any reports of adverse events related to this recall.

Robitussin Honey CF Max Day and Nighttime are cough syrups indicated for the temporary relief of symptoms occurring with cold or flu, hay fever, or other respiratory allergies.

Robitussin Honey Severe Cough, Flu + Sore Throat CF Max Daytime
Active Ingredients (in each 20mL)
Acetaminophen, USP 650 mg (pain reliever/fever reducer)
Dextromethorphan HBr, USP 20 mg (cough suppressant)

Robitussin Honey Severe Cough, Flu + Sore Throat CF Max Nighttime
Active Ingredients (in each 20mL)
Acetaminophen, USP 650 mg (pain reliever/fever reducer)
Diphenhydramine HCl, USP 25 mg (antihistamine/cough suppressant)

This recall covers only the following lots:

Product Lot Number Expiry Date
ROBITUSSIN HONEY CF MAX
DAY ADULT 4OZ
T10810 31OCT2025
ROBITUSSIN HONEY CF MAX
DAY ADULT 8OZ
T08730
T08731
T08732
T08733
T10808
31MAY2025
31MAY2025
31MAY2025
31MAY2025
30SEP2025
ROBITUSSIN HONEY CF MAX
NT ADULT 8OZ
T08740 T08742 30JUN2026
30JUN2026

Haleon is notifying its distributors and customers directly and has provided them with instructions for the return of all recalled products. Consumers that have purchased the product listed should stop consumption immediately. Please call our Consumer Relations team at +1-800-245-1040 (Monday through Friday 8 AM to 6 PM Eastern Time) or reach out via email to mystory.us@haleon.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

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