FDA Issues Recall of Cough Medicine

The Office of Developmental Programs (ODP) has shared this important announcement from the U.S. Food and Drug Administration (FDA) about a recall of two cough medicine products by Robitussin. The products are Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult. Please see the specific Lot Numbers below that are involved in the recall.  If you have one of these products with the matching Lot Number, stop use immediately and contact your health care provider.

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

Summary
Company Announcement Date: January 24, 2024
FDA Publish Date: January 24, 2024
Product Type: Drugs
Reason for Announcement: Microbial Contamination
Company Name: Haleon
Brand Name: Robitussin
Product Description: Cough syrups

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. This recall covers only the following lots:

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 8:00 am – 6:00 pm Eastern Time) or reach out via email.

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.

• Complete and submit the report online
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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