FDA Recalls: Costco Cold & Flu Medicine Pulled
FDA recalls are in the news again this week, and the biggest name involved is Costco. The Food and Drug Administration recalled 8,640 boxes of Kirkland Severe Cold & Flu Plus Congestion Day and Night packs, Costco’s store brand, last week, pulling a widely sold cold and flu medicine from shelves just as flu season is getting under way. The recalled boxes carry lot numbers P139953 or P139815 with an August 2026 expiration date, and shoppers who bought the product should check the lot number on the box they have at home. The recall is a Class II recall, related to quality control issues, and it arrives at a moment when many households are stocking up on cold and flu remedies for the winter months ahead.
FDA Recalls: The Kirkland Cold and Flu Recall Explained
The Kirkland recall covers 8,640 boxes of Severe Cold & Flu Plus Congestion Day and Night packs, the store-brand cold and flu medicine sold by Costco under its Kirkland label. The boxes to look out for carry lot numbers P139953 or P139815, and they have an August 2026 expiration date. Those two details, the lot number and the expiration date, are the way to tell whether a box at home is part of the recall, and they are printed on the packaging. The recall is a Class II recall, which the FDA uses for a situation where use of the product may cause temporary or medically reversible adverse health consequences. That definition matters, because it tells shoppers how serious the problem is: it is not a case where the product is expected to cause lasting harm, but it is a case where the product should not be used as sold.
The reason for the recall is related to quality control issues. Pharmacist Katy Dubinsky, founder and CEO of Vitalize in New York, told Fox News Digital that the recall most likely occurred due to deviations from Current Good Manufacturing Practice, known as CGMP. That is the set of standards that manufacturers are expected to follow when they make medicines, covering how products are produced, tested, and checked before they reach the shelves. The point of the system is to catch problems before they reach patients, and a recall is the mechanism the FDA uses when a problem is found after the product has already been sold.
Oral Phenylephrine and the FDA Proposal
The Kirkland recall follows a separate development from the FDA that affects the same shelf of the pharmacy. In early November, the FDA proposed to ban oral phenylephrine as an over-the-counter nasal decongestant. After what the agency described as extensive review, the FDA concluded that oral phenylephrine is not effective as a nasal decongestant, a finding that could reshape a whole category of cold and flu products. Phenylephrine is a common ingredient in over-the-counter cold and flu medicines, and many shoppers will have bought products containing it without ever reading the ingredient list closely. The proposal is a significant step, because it would remove the ingredient from the over-the-counter market altogether if it goes ahead.
Reports note a further concern about the ingredient: at a dose where it might work, it carries heart risks including palpitations and arrhythmia. That combination, a lack of effectiveness at the usual dose and a risk to the heart at a higher dose, is the heart of the FDA’s case for the ban. For shoppers, the practical point is that the cold and flu aisle is changing, and that the products they have relied on for years may not be the same in future. The Kirkland recall and the phenylephrine proposal are separate actions, and the recall was not described as being caused by phenylephrine, but they arrive together and they both point in the same direction: the FDA is looking closely at the medicines people take for colds and flu, and it is prepared to act when the evidence points to a problem.
Flu Season News: An Early Start and the Shot Deadline
Flu season news this week carries a warning that the season is running about a month early. Dr. Stephen Miller, health officer for the Hamilton County Health Department, told Local 3 News that Tennessee and Hamilton County have seen a little spike in the last couple of weeks, an early rise that suggests the season is under way sooner than usual. An early flu season matters because it shortens the time people have to get protected, and it means the virus is already circulating in communities while many people have not yet had their flu shot. The spike described by Dr. Miller is local to Tennessee and Hamilton County, but the pattern it points to is one that health officials watch everywhere, because an early start in one place can be a sign of what is coming elsewhere.
The CDC says a flu shot takes about two weeks to start working, and that timing creates a clear deadline for anyone planning to be protected by Thanksgiving. Thanksgiving falls on Thursday, November 26, which is two weeks from November 12, so health officials urge people to get the shot this week if they want it to be working by the holiday. Getting the shot this week is the practical step that follows from the two-week window, and it is the message health officials are repeating as the early season takes hold. The flu shot does not guarantee that a person will not catch flu, but it is the main tool available for reducing the risk, and the two-week lead time is the reason the advice is to act now rather than later.
Other November 12 FDA Recalls: Hidden Drugs Found in Supplements
The Kirkland recall was not the only FDA recall announced on November 12, and two of the others involved products that were found to contain hidden drugs. “10 Day Forecast” capsules, in the 3,200 mg strength with UPC 191645852717 and covering all lots, were recalled after FDA testing found hidden sildenafil, the drug in Viagra, and acetaminophen. Sildenafil is a prescription drug, and its presence in a product that does not declare it is a serious problem, because people taking the product would not know they were taking a prescription medicine, and they would not know about the risks that come with it, including interactions with other medicines. Acetaminophen, the pain reliever found in many common medicines, adds a further risk, because people who take it unknowingly could end up taking too much of it across different products.
“Candy Power For Man” organic honey, in a yellow and orange box of 60 wrapped candies, batch 241020, UPC 5285002251390, was also recalled after FDA testing found hidden tadalafil, the drug in Cialis. The product was sold on eBay from April 27 to July 20, 2026, which means it was available for nearly three months before the recall. Tadalafil, like sildenafil, is a prescription drug, and its hidden presence in a food product is dangerous for the same reason: the person eating it does not know they are taking a medicine, and the medicine can interact with other drugs, particularly those taken for heart conditions. The two recalls together are a reminder that products sold as supplements or food can sometimes contain ingredients that are never listed on the label, and that FDA testing is one of the few ways such hidden ingredients are discovered.
Food Recall News: Raw Cheddar Cheese and Listeria
Food recall news this week includes a cheese recall that affects shoppers in twelve states. Family Farmstead Dairy of Worcester, New York is recalling all of its raw cheddar cheese because it may be contaminated with Listeria monocytogenes, according to a company announcement that the FDA posted on November 10. The recall covers every raw cheddar lot dated 10/16/27 or earlier, including Raw Mild and Raw Sharp Cheddar in 8 oz plastic-wrapped packages, and the cheese was sold in retail stores in New York, New Jersey, Vermont, New Hampshire, Massachusetts, Pennsylvania, Rhode Island, Connecticut, Delaware, Virginia, West Virginia, and Tennessee. The breadth of the recall, covering all lots up to a given date across a dozen states, shows how widely a single dairy’s products can travel through retail stores.
Listeria is a serious concern, and the people who face the greatest risk from it are pregnant people, newborns, adults aged 65 and older, and people with weakened immune systems. For most healthy adults, a Listeria infection may cause milder symptoms, but for those in the higher-risk groups it can cause severe illness, and pregnancy carries the added risk of harm to the unborn child. That is why a Listeria recall is treated seriously even when no illnesses have been reported, and no illnesses have been reported in connection with either cheese recall. The absence of reported illnesses is welcome news, but it does not change the advice: the cheese should not be eaten, and anyone who bought it should check the date on the package and follow the recall.
It is the company’s second cheddar recall in under a month, which makes the story more worrying. In October, a Maryland laboratory sample found two strains of Shiga toxin-producing E. coli in its raw cheddar, leading to the earlier recall. Two recalls in such a short period, for two different contaminants, suggest a wider problem at the dairy, and it is a reminder that raw cheese carries particular risks, because it is made from unpasteurised milk and does not go through the heating step that kills bacteria in pasteurised products. Shoppers who buy raw cheese are choosing a product with a different risk profile from ordinary cheese, and the two recalls in quick succession show what that risk can look like in practice.
Moringa Leaf Powder and the Wider Recall Picture
There was one more food recall to note. Moringa leaf powder products, specifically the Food to Live brand organic moringa leaf powder with lot codes SO-69006 through SO-72558, were recalled over potential Salmonella contamination, with 11 illnesses reported. Salmonella is a familiar cause of food poisoning, and the eleven illnesses linked to this product are a reminder that a recall is not always a precaution taken before anyone is harmed. In this case, people had already become ill, and the recall followed. Moringa leaf powder is sold as a health food, which makes the contamination particularly unwelcome for the people who bought it in the belief that they were making a healthy choice.
Source: FDA