Costco customers have recently found themselves dealing with yet another headache—this time involving a recall of their off-brand Kirkland Signature Severe Cold & Flu Plus Congestion, which has been pulled from shelves due to quality control issues. The recall, which affects more than 8,600 boxes of the product, serves as a reminder of the dangers that can arise from unregulated or poorly manufactured over-the-counter medications.
The U.S. Food and Drug Administration (FDA) announced the recall last week after the medication was found to fall short of the agency’s stringent manufacturing standards. Despite the fact that oral phenylephrine, a key ingredient in the product, is already under scrutiny for its ineffectiveness as a nasal decongestant, this recall is unrelated to that issue. In fact, the recall pertains exclusively to “CGMP deviations”—or failures to meet the *Current Good Manufacturing Practices* (CGMP) that are meant to ensure drug quality and safety.
Kirkland Signature Severe Cold & Flu Plus Congestion, sold at Costco nationwide, is a 168-count package consisting of both day and night capsules designed to combat the symptoms of severe cold and flu. The daytime capsules are formulated to relieve pain, reduce fever, suppress cough, and promote decongestion, while the nighttime capsules contain added antihistamines to help with throat and nasal symptoms and to induce sleep. Retailing for $15.99, the product was intended to offer consumers an affordable alternative to popular brand-name medications like Vicks Dayquil and Nyquil.
But now, customers are faced with the unpleasant reality that their cold remedy may not meet the quality standards they expect, or deserve, from a major brand like Costco. The FDA noted that the product “should have been rejected” during the manufacturing process, though specifics on what exactly went wrong remain undisclosed.
This recall has triggered frustration not only due to the inconvenience of having to dispose of or return the products but also because of the broader question surrounding Costco’s quality control measures. The recall, which the FDA has classified as a Class II recall, suggests that the health risks posed by the affected products are temporary or reversible, with serious health consequences considered unlikely. However, this does little to ease the concerns of customers who placed their trust in the retailer’s own-brand offerings.
The Kirkland cold medicine is identified by the National Drug Code (NDC) number 63981-795-81 and specific lot numbers: P139953 or P139815, with an expiration date of August 2026. If you purchased this product, the FDA urges you not to consume it and to either dispose of it or return it to Costco for a refund.
This isn’t the only controversy making waves at Costco lately. As if a tainted cold remedy wasn’t enough, the retailer is also facing growing outrage over a 58% price increase on its beloved muffins—a staple for many Costco shoppers. On top of that, rumors are swirling that Costco plans to stop selling books at most of its U.S. stores early next year, further fueling consumer ire.
While the Kirkland cold medicine recall is a health issue, these other changes point to a growing dissatisfaction among Costco shoppers. Whether it’s defective cold meds, rising food prices, or losing access to popular books, Costco’s recent missteps have left many questioning their once-unwavering loyalty to the retailer. For now, customers are left with the unpleasant task of returning their faulty cold meds—along with a growing sense of frustration with Costco’s shifting priorities.