Safety Report: Robitussin Cough syrups - recalled due to microbial contamination, USA

United States

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

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.

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

Haleon is notifying its distributors and customers directly and has provided them with instructions for the return of all recalled products. Consumers who have purchased the product listed should stop consumption immediately.

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

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Haleon
Brand name: Robitussin
Product recalled: Cough syrups
Reason of the recall: Microbial Contamination
FDA Recall date: January 24, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/haleon-issues-voluntary-nationwide-recall-robitussin-honey-cf-max-day-adult-and-robitussin-honey-cf