The manufacturer of Robitussin, Haleon, is voluntarily recalling eight lots of its cough syrup due to microbial contamination.
The Food and Drug Administration published a press statement on Haleon’s behalf late last night, saying that the company is in direct communication with distributors and customers to provide instructions for returning recalled products.
Eight different lot numbers of Robitussin Honey CF Max Day and Nighttime may have been exposed to contamination.
Life-threatening infections are not likely for most consumers of the product, but “the occurrence of an infection that may necessitate medical intervention cannot be completely ruled out,” the FDA warning reads.
Those at the highest risk of developing “severe or life-threatening” complications are those with other immunocompromising conditions.
“To date, Haleon has not received any reports of adverse events related to this recall,” said the FDA.
Last fall, the FDA issued a wide-reaching recall of eye drop products due to contamination at various overseas manufacturing plants. Regulators are more cautious of products placed directly in the eyes due to their sensitivity and lack of immune system protections.
Aside from recalls, the market for cold and flu products has also shifted in recent months as the FDA advised pharmaceutical companies that the common oral decongestant phenylephrine does not meet the agency’s efficacy standards. Although the FDA has not recalled the decongestant officially, CVS in October voluntarily pulled from its shelves all products containing oral phenylephrine.
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Robitussin is the second most effective popular over-the-counter cough suppressant, ranked below Delsym, according to US News and World Report.
The specific lot number and expiration date of the recalled Robitussin can be found on the lower right corner of the bottle’s back label. Consumers should visit the FDA website for more information.