01/25/2024
The Office of Developmental Programs is sharing 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.
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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
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
Company Announcement
FOR IMMEDIATE RELEASE – 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.
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
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 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.
• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.
Reporting on prescription/OTC medicines, non-vaccine biologicals, medical devices, special nutritional products, cosmetics and non-prescription human drug.
