If You Take This Medication, Call Your Doctor Now, FDA Says

This isn't the first time this common prescription has been pulled from the market this year.

When it comes to improving your overall wellbeing, finding the right prescription medication to treat your health issues can be a serious game-changer. And while many medications are associated with minor side effects to users, others may pose a more serious and immediate threat to those prescribed them. That just so happens to be the case with one medication by Pfizer, which is now subject to its second recall this summer over the possible health risks it may present. Read on to find out if a medication you take is subject to the recall and what to do if you have the affected medication at home.

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The FDA just announced the recall of four lots of Chantix.

chantix packet on gray desk
Shutterstock/Antwon McMullen

On Aug. 16, the FDA announced that Pfizer had voluntarily recalled four lots of Chantix, a medication used to help patients quit smoking.

The medications affected by the recall include 56-count bottles of Chantix 0.5 mg tablets, 56-count bottles of Chantix 1 mg tablets, and cardboard boxes containing blister packs of 0.5 mg Chantix tablets and 1 mg Chantix tablets. Photos of the newly recalled medications, which were distributed within the U.S. and Puerto Rico between June 2019 and June 2021, can be found on the FDA website.

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Multiple lots of Chantix were recalled in July.

Woman taking supplement pills

This isn't the first time that Chantix has been subject to a recall in recent months. On July 19, the FDA announced that Pfizer had recalled two lots of Chantix 0.5 mg tablets, two lots of Chantix 1 mg tablets, and eight lots of packaging that included a combination of Chantix 0.5 mg and 1 mg tablets.

The full list of lot numbers, expiration dates, and NDC numbers for the prescriptions recalled in July can be found on the FDA website.

The medication may contain an ingredient that can cause serious health issues.

Doctor listening to patient's heartbeat

According to the recall notice, the medication is being recalled due to the presence of N-nitroso-varenicline, a type of nitrosamine, that exceeds the Acceptable Daily Intake (ADI) threshold dictated by Pfizer.

"Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication," the recall notice states. The Chantix recall in July was related to the same potential contamination concerns.

If you are taking this medication, talk to your doctor immediately.

doctor talking and explaining test result and diagnosis to demoralized elderly patient in hospital hallway

If you take Chantix, talk to your doctor as soon as possible to determine whether your medication is affected by the recall. However, the recall notice explains that continuing Chantix treatment may still be on the table for some patients. "The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline," according to the recall notice.

That said, Pfizer is recommending that any wholesalers or distributors of Chantix with the recalled medications in their possession stop distributing the medication and quarantine the product to prevent future patient access. If your medication is subject to recall, you can call Stericycle Inc. at 888-276-6166 on weekdays from 8 a.m. to 5 p.m. to find out how to appropriately return the medication and how you can go about seeking a refund.

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Sarah Crow
Sarah Crow is a senior editor at Eat This, Not That!, where she focuses on celebrity news and health coverage. Read more
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