Costco brand cold and flu medicine recalled by FDA: Here’s what to know

Thousands of Costco brand cold and flu medicines were pulled from shelves.

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

This follows a proposal by the FDA to ban the use of oral phenylephrine as an over-the-counter decongestant in early November.

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After “extensive review,” the FDA concluded that the active ingredients in the product (oral phenylephrine) is “not effective” at relieving nasal congestion.

Nearly 9,000 boxes of Kirkland Severe Cold & Flu Plus Congestion Day and Night are being recalled due to quality control issues. (Istock)

Dr. Marc Siegel, senior medical analyst for Fox News, said he agrees with the backlash to the ingredient.

“This chemical has been shown to not protect against colds and flu orally. Except in doses that are toxic to the heart. and may lead to heart palpitations Arrhythmia and high blood pressure.”

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The FDA says the Kirkland recall is related to quality control issues. It was stated in the official recall that “Products on sale should be rejected.”

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

The recalled boxes of Kirkland Severe Cold & Flu Plus Congestion have lot numbers P139953 or P139815, with an expiration date of August 2026. (ebay)

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

“(This means) the product does not meet required quality control standards. And it should be rejected before it goes on sale,” she said.

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“To ensure that all products meet strict safety and quality guidelines, the FDA is recalling the Category II product, which indicates low risk to consumers. and generally deal with issues that are unlikely to cause serious harm.”

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Pharmacists say manufacturing inconsistencies and labeling errors can cause “many” deviations and other procedural problems. More than an ingredient problem

“Acetaminophen, dextromethorphan, guaifenesin, and phenylephrine which is the listed active ingredient It is widely used and considered safe when taken as directed,” she said.

Pharmacist Katy Dubinsky tells consumers to stop using many of the recalled products. (Istock)

Dubinsky recommends that consumers stop using the recalled products. and consult a health care professional If you have concerns or symptoms after eating the product

“however There is no need to panic,” she said. “Recalls like this are important to keeping products safe and helping people trust the over-the-counter medicines they rely on.”

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The boxes of recalled Kirkland Cold & Flu products have lot numbers P139953 or P139815, with an expiration date of August 2026.

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