Thousands of Costco-branded cold and flu medicines have been pulled from shelves.
A total of 8,640 boxes of Kirkland Severe Cold and Flu Plus Crowded Daypacks and Nightpacks were recalled by the Food and Drug Administration (FDA) last week.
This follows the FDA's proposal in early November to ban the use of oral phenylephrine as an over-the-counter nasal decongestant.
Food and beverage product recalls in December: It's all about 'protecting consumers'
After an “extensive review,” the FDA concluded that the product's active ingredient (oral phenylephrine) is “ineffective” as a nasal obstructor.
A total of nearly 9,000 boxes of Kirkland Severe Cold/Influenza Plus Congestion Day and Night have been recalled due to quality control issues. (St. Petersburg)
FOX News senior medical analyst Dr. Mark Siegel said he agrees with the recent backlash against the ingredient.
“This chemical has been shown to be ineffective against colds and flu when taken orally, except at doses that are cardiotoxic and can cause palpitations, arrhythmias, and high blood pressure.”
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The FDA said the Kirkland recall was related to a quality control issue, noting that “the released product should have been rejected” in the official recall.
This is a Class II recall, which the FDA defines as “situations where use or exposure to a violative product is likely to cause a temporary or medically reversible health hazard, or where the likelihood of a serious health hazard is low.” situation.”
The recalled boxes of Kirkland Severe Cold and Flu Plus Congestion had lot numbers P139953 or P139815 and had an expiration date of August 2026. (ebay)
Katie Dubinsky, a New York pharmacist and founder and CEO of Vitalize, told Fox News Digital that the recall may have been caused by a deviation from current good manufacturing practices (CGMP). He admitted that he has a high level of sexuality.
”[That means] “This product did not meet the required quality control standards and should have been rejected before it was released,” she said.
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“To ensure that all products meet strict safety and quality guidelines, the FDA has issued a Class II recall, which suggests a low risk to consumers. We are usually dealing with problems that are unlikely to cause serious harm.”
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Pharmacists say manufacturing discrepancies and labeling errors can cause “many” CGMP deviations, as well as other procedural issues rather than ingredient issues.
“The active ingredients listed, acetaminophen, dextromethorphan, guaifenesin, and phenylephrine, are widely used and considered safe when taken as directed,” she said.
Pharmacist Katie Dubinski urged consumers to stop using the large quantities of the recalled product. (St. Petersburg)
Dubinsky instructed consumers to stop using the recalled lots and consult a medical professional if they develop concerns or symptoms after consuming the product.
“But there's no need to panic,” she said. “Recalls like this are important to keeping products safe and people trusting the over-the-counter medicines they rely on.”
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The recalled boxes of Kirkland cold and flu products had lot numbers P139953 or P139815 and had an expiration date of August 2026.
Fox News Digital has reached out to the FDA and Costco for comment.
