The U.S. Food and Drug Administration (FDA) has announced a recall of Kirkland Severe Cold & Flu Plus Congestion medication, an off-brand version of DayQuil and NyQuil, citing manufacturing concerns.
The cold and flu medicine has been sold at Costco.
According to the FDA, the recall affects 8,640 boxes of the product, which includes both day and night versions of the over-the-counter medicine.
The day version contains 112 coated caplets with acetaminophen, dextromethorphan HBr, guaifenesin, and phenylephrine HCl. The night version consists of 56 coated caplets containing acetaminophen, dextromethorphan HBr, doxylamine succinate, and phenylephrine HCl.
The recall, classified as Class II by the FDA, was initiated by LNK International, Inc., the manufacturer of the product for Costco Wholesale Corporation.
The FDA states that the reason for the recall is “CGMP Deviations: Released product should have been rejected,” indicating issues with how the medicine was manufactured. CGMP stands for Current Good Manufacturing Practices.
Those affected can be identified by lot numbers P139953 and P139815, both with an expiration date of August 2026. The FDA reports that the product was distributed to one wholesale retail customer, who may have further distributed it nationwide.
The recall is ongoing, and those who have purchased the affected product are advised to check the lot numbers and expiration dates.
A Costco spokesperson didn’t immediately respond to NTD’s request for comment.
Ingredient Under Scrutiny
The recall comes as one of the medication’s ingredients—phenylephrine—has come under FDA scrutiny. As listed in the recall, phenylephrine HCl is phenylephrine in its hydrochloride form, making it more suitable for use in medication.
On Nov. 7, the FDA proposed removing oral phenylephrine from over-the-counter nasal decongestant products due to concerns with its effectiveness.
“Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER).
In response, the Consumer Healthcare Products Association (CHPA) stated they do not support the FDA’s proposal, citing the positive effects of the drug commonly abbreviated as PE.
“For decades, people have relied on oral PE to relieve their nasal congestion. We believe Americans deserve access to safe and effective OTC medicines and the option to choose the products they prefer for self-care,” said CHPA President and CEO Scott Melville.
“PE is the only oral OTC decongestant available without purchase restrictions and is included in numerous OTC cough and cold medicines labeled with a decongestant claim. Consumers need options for self-care, and freedom of choice for self-care is a core attribute of our nation’s healthcare system,” Melville said.