It's a big-box chain's version of Dayquil & Nyquil. Here are the details on two recalled lots, with expiration dates very active.
Nearly 9,000 Boxes of Cold and Flu Medicine Were Just Recalled by a Major Retailer
Published on Dec. 13, 2024
Many Costco members may know this as the season to enter the store slowly and browse the health and wellness displays that are positioned immediately upon entry. But if you’ve stocked up on Costco’s version of Dayquil and Nyquil, note their house brand of cold and flu capsules are being pulled from shelves due to what national experts have determined is substandard quality.
On Thursday, December 12, a report was released that on November 14, the U.S. Food and Drug Administration (FDA) announced a recall on 8,640 boxes of Kirkland Severe Cold & Flu Plus Congestion, sold nationwide at Costco stores near the pharmacy section. Wording on the packaging reads: Compare to Vicks Dayquil & Nyquil Vapocool Severe Cold & Flu Congestion. The market analytics group YouGov ranks Nyquil as the number-seven most popular medicine on the market. Costco’s 84-dose package appears to retail for $15.99 US.
The FDA reports this Kirkland Signature cold and flu medicine recall is due to “CGMP deviations.” This means that the product was out of accordance with a set of quality control regulations known as Current Good Manufacturing Practices. Though the notice states that the “released product should have been rejected,” it does not specify which specific quality measures it failed to meet.
Earlier this week, on December 9, the incident was designated a Class II recall in the FDA’s three-tier system that indicates the level of risk for consumers. This means the FDA calls this “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.”
The Kirkland cold and flu medicine pairs 112 coated caplets intended for day use and 56 coated caplets intended for night use in a 168-count twin-pack. The box design is split down the middle to indicate the two types of pills, with orange on the left to indicate daytime use and blue on the right to indicate nighttime use. At the top of the box, the words Severe Cold and Flu appear in white block lettering.
There are several identifying codes printed on the label, which may further help you spot the affected product in your own medicine cabinet:
- National Drug Code/NDC number: 63981-795-81
- Lot numbers: P139953 or P139815
- Expiration date: August 2026
According to the National Institutes of Health’s (NIH) National Library of Medicine, the daytime capsules are most often used to reduce pain and fever, suppress cough, lubricate the airways, and promote decongestion. The nighttime capsules add antihistamines, which can treat throat and nasal symptoms, while also promoting drowsiness.
The recall comes amid recent news that one of the product’s key ingredients, oral phenylephrine, may soon be banned from cold and flu medications altogether due to ineffectiveness. “Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold,” said Theresa Michele, MD, director of the Office of Nonprescription Drug Products in CDER, via an FDA news release. “Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.”
The items that are currently being called back were developed by LNK International, Inc., a family-owned pharmaceutical manufacturer located on Long Island, New York. The company produces more than 150 over-the-counter formulas of pain relievers, cough and cold medications, and gastro-intestinal treatments for multiple brands.
If you have purchased the affected cold and flu capsules, do not take them. Throw them away or return them to your place of purchase.
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