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OTC Pain and Fever Meds Recalled Over "Health Risk," FDA Warns

Officials are telling consumers not to use the affected items, which were sold nationwide.

We often rely on over-the-counter (OTC) medicines to help deal with some of the worst symptoms brought on by coming down with a bug. Whether it's keeping a cough at bay, relieving aches and pains, or driving down a fever, they can often be a saving grace when we're feeling our worst. But this cold and flu season, you might want to double-check what you've got stashed in your cabinet after OTC pain and fever meds were recalled over a potentially serious health risk. Read on to see if you're affected and what you should do if you have the products in your home.

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The FDA just announced a recall for two types of OTC pain and fever meds for infants and children.

A man looking at a bottle he has just taken from his medicine cabinet
Shutterstock / Boris023

On Nov. 17, the U.S. Food & Drug Administration (FDA) announced that Los Angeles, California-based KinderFarms, LLC had voluntarily recalled two of its OTC pain and fever meds made for children and infants. The move affects all lots of its KinderMed Infants' Pain & Fever (2 fluid ounces/59 mL), (Acetaminophen – 160 mg per 5 mL), Oral Suspension; and KinderMed Kids' Pain & Fever (4 fluid ounces/118 mL), (Acetaminophen – 160 mg per 5 mL), Oral Suspension. The items have the UPCs 850001805698 and 850001805728, respectively.

The affected products were sold nationwide in pharmacies, drug stores, supermarkets, and other national retailers. They were also sold online and through direct delivery from the company.

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The company pulled the products due to a potential "health risk" from the drugs' active ingredient.

baby receiving oral medicine

In its notice, KinderFarms says it initiated the recall due to potential "instability" issues with the medicines' active ingredient, acetaminophen.

"The two products were manufactured and packaged for KinderFarms by a major, U.S.-based OTC pharmaceutical manufacturer with over 30 years of experience," the company wrote. "Ongoing testing of sample batches indicated some product lots were no longer in specification and may pose a health risk."

Acetaminophen is commonly used in OTC pain relievers and fever reducers. However, the company warns that the products being outside of specification could cause some serious adverse health effects, including "abdominal pain, nausea, vomiting, or jaundice at higher doses."

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Here's what you should do if you have the recalled medicines in your home.

A woman checking the label of a medicine bottle
iStock / fizkes

So far, KinderFarms says it hasn't received any reports of serious health events related to the recalled medicines. It also specified that the latest move affected none of its other products.

However, the company says that anyone who purchased the medicines or has them in their cabinets should stop using them. Instead, they can return them to their place of purchase for a full refund. Anyone with questions can also reach KinderFarms by emailing or calling the company using the contact information posted on the FDA's notice.

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There have recently been some other recalls for OTC meds.

A woman peruses the shelf at a pharmacy, reading the label.

While plenty of rules and regulations are in place to protect customers, this isn't the only time recently that OTC meds have been pulled from shelves. On Oct. 10, the FDA shared an alert from Family Dollar that it had voluntarily recalled "certain OTC drugs and medical devices" regulated by the agency that it had shipped to its stores across 23 states.

The retailer's notice included an eight-page-long list of common medicine cabinet staples, including popular OTC meds like Advil, Nyquil, Dayquil, Aleve, Tylenol, Benadryl, Pepto Bismol, and many more. Other daily essentials and toiletries were also affected, including toothpaste, mouthwash, chapstick, shampoo, soap, and moisturizer.

The company explained it issued the recall after discovering the items were mishandled en route to stores. "These items were stored outside of labeled temperature requirements by Family Dollar," the retailer wrote.

And on Oct. 27, the FDA issued a warning to consumers not to purchase or use 26 different OTC eye drop products marketed under the CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up&Up, and Velocity Pharma brands. The agency said it became concerned for public safety after its investigators found unsanitary conditions and brought back "positive bacterial test results from environmental sampling of critical drug production areas in the facility." The FDA explained that bacterial contaminations could result in "eye infections that could result in partial vision loss or blindness."

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Zachary Mack
Zach is a freelance writer specializing in beer, wine, food, spirits, and travel. He is based in Manhattan. Read more
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