FDA recalls Costco-brand cold and flu medication due to ineffectiveness.

Thousands of Costco-brand cold and flu medicines have been removed from store shelves.

Last week, the Food & Drug Administration (FDA) recalled 8,640 boxes of Kirkland Severe Cold & Flu Plus Congestion Day and Night packs.

In early November, the FDA proposed banning the use of oral phenylephrine as an over-the-counter nasal decongestant.

The FDA concluded that the active ingredient in the product (oral phenylephrine) is "not effective" as a nasal decongestant after conducting an "extensive review."

Dr. Marc Siegel, a senior medical analyst at Planet Chronicle, concurs with the recent opposition to the ingredient.

"The chemical is ineffective against cold and flu in its oral form, except at a dose that can cause heart toxicity and lead to palpitations, arrhythmia, and high blood pressure."

The FDA stated that the Kirkland recall was due to quality control issues, stating in the official recall that the product should have been rejected.

The FDA defines a Class II recall as a situation where the use of or exposure to a non-compliant product may cause temporary or reversible adverse health effects, with a low probability of serious consequences.

According to Katy Dubinsky, the founder and CEO of Vitalize, the recall was most likely caused by deviations from CGMP.

She stated that the product did not meet the required quality control standards and should have been rejected prior to release.

"The FDA issued a Class II recall to ensure that all products adhere to stringent safety and quality standards, which implies a low risk to consumers and usually addresses problems unlikely to cause severe harm."

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According to the pharmacist, inconsistencies and labeling errors can lead to deviations from CGMP standards, as well as other procedural issues, rather than ingredient problems.

The active ingredients, including acetaminophen, dextromethorphan, guaifenesin, and phenylephrine, are widely used and considered safe when taken as directed, she stated.

Consumers were advised by Dubinsky to cease using the recalled lots and seek medical advice if any health concerns or symptoms arose after using the product.

"Nevertheless, it is crucial to remember that recalls are necessary to ensure the safety of over-the-counter medications and maintain public trust in them."

The Kirkland Cold & Flu product with lot numbers P139953 or P139815 and an August 2026 expiration date was recalled.

Planet Chronicle Digital reached out to the FDA and Costco for comment.