Costco-brand cold and flu medication recalled by FDA: ‘Not effective’

A Costco-brand cold and flu medicine has been pulled from shelves by the thousands.

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

This is following the FDA’s proposal to ban the use of oral phenylephrine as an over-the-counter nasal decongestant in early November.

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After “extensive review,” the FDA concluded that the active ingredient in the product (oral phenylephrine) is “not effective” as a nasal decongestant.

Dr. Marc Siegel, Fox News senior medical analyst, said he agrees with the recent pushback against the ingredient.

“This chemical is shown to be ineffective against cold and flu in its oral form, except at a dose that has some heart toxicity and can lead to palpitations, arrhythmia and high blood pressure.”

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The FDA stated that the Kirkland recall was related to quality control issues, noting in the official recall that the “released product should have been rejected.”

This was a Class II recall, which the FDA describes as a “situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Recalled boxes of Kirkland Severe Cold & Flu Plus Congestion had lot numbers P139953 or P139815 with an August 2026 expiration date. (eBay)

Katy Dubinsky, a New York pharmacist and founder and CEO of Vitalize, confirmed with Fox News Digital that the recall most likely occurred due to deviations from CGMP (Current Good Manufacturing Practice).

“[That means] the product failed to meet required quality control standards and should have been rejected before release,” she said.

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“To guarantee all products meet strict safety and quality guidelines, the FDA made a Class II recall, which suggests low consumer risk and typically addresses issues unlikely to cause serious harm.”

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Manufacturing inconsistencies and labeling errors can cause “many” CGMP deviations, according to the pharmacist, as well as other procedural issues rather than ingredient problems.

“Acetaminophen, dextromethorphan, guaifenesin and phenylephrine – the listed active ingredients – are widely used as well as considered safe when taken as directed,” she said.

Pharmacist Katy Dubinsky told consumers to stop using recalled lots of this product. (iStock)

Dubinsky instructed consumers to stop using the recalled lots and consult with a health care professional if concerns or symptoms arise after taking the product.

“However, there is no need for panic,” she said. “Recalls like this are important to keep products safe and help people trust the over-the-counter medications they rely on.”

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Recalled boxes of the Kirkland Cold & Flu product had lot numbers P139953 or P139815 with an August 2026 expiration date.

Fox News Digital reached out to the FDA and Costco for comment.