Over 140,000 bottles of cholesterol medication nationwide recalled — See affected products and brands across the United States

FDA issues nationwide Class II recall for Atorvastatin Calcium after manufacturing concerns — here’s how to find out if your cholesterol medication is affected

Modified on:
October 24, 2025 7:02 pm

A large recall that’s hitting the headlines

If you or a relative take medication for high cholesterol, you’ll want to look in pill bottles right away. Over 140,000 bottles of Atorvastatin Calcium — a generic version of Lipitor — have been recalled across the United States.

The recall came after the pills supposedly “failed dissolution specifications,” which literally means they might not break down properly in the body—and that could affect how well they function. The U.S. Food and Drug Administration (FDA) put the recall on a formal enforcement report and confirmed the medication was distributed throughout the nation.

The recalled tablets were manufactured by Alkem Laboratories in India and sold by New Jersey’s Ascend Laboratories. The offending pills are packaged in bottles of 90, 500, or 1,000 tablets, some with expiration dates as far away as February 2027.

What the FDA says about the risk

On October 10, the FDA officially designated the recall as Class II, which means that while the drug could have short-term or medically reversible side effects, there is a “remote” risk of any serious health concerns.

That’s some relief for the 39 million Americans who swallow statins every day to reduce cholesterol and prevent heart disease. However, if your tablets are from one of the batches, the FDA highly advises checking before taking another dose.

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Why this matters: Statins are everywhere

Statins are one of the most prescribed drugs in America. According to Cleveland Clinic’s Dr. Tamanna Singh, people above the age of 40 constitute the widest majority, often taking them as a precaution against heart attack and stroke.

The big names in this category include Lipitor (brand name) and its generic version, Atorvastatin. So, if you’ve filled a prescription recently, it’s worth taking a closer look at your bottle’s label.

The recalled products — Check your lot numbers

Here’s a quick breakdown of what’s included in the recall:

  • Atorvastatin Calcium Tablets USP, 10 mg, 20 mg, 40 mg, and 80 mg
  • Sold in bottles of 90-count, 500-count, and 1,000-count
  • Expiration dates between February 2026 and June 2027
  • Lot numbers are 25141249, 24144938, 24144868, 24144254, 25140150, 25140249, and other numbers identified by the FDA
  • If your bottle has any of these lot numbers, you might have the recalled product in your hands.

What should you do if you have the recalled pills?

So far, the FDA and Ascend Laboratories have not given precise instructions on what to do with the recalled bottles. However, this is what GoodRx and other healthcare experts recommend:

  • Check your bottle’s lot number – It is usually stamped on or near the barcode or side panel.
  • Call your pharmacy – They can check if your prescription is part of the recall.
  • Call your physician or prescriber – Don’t suddenly stop taking your medication without the guidance of a professional.
  • Dispose of recalled pills safely – Take part in a take-back programme at a pharmacy or follow FDA disposal guidelines.

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A Growing trend of safety recalls

This Atorvastatin recall isn’t the only major one to hit recent weeks. The FDA has also tracked recalls on Evenflo child car seats, State Fair and Jimmy Dean foods, and even Oster countertop ovens — proving that product safety concerns still cross a variety of industries.

Drug recalls, especially, tend to be done as a precaution. But for drugs as essential as statins, even a small quality issue is big news.

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Emem Ukpong
Emem Ukponghttps://polifinus.com/author/emem-uk/
My journey to becoming a writer has been shaped by both science and finance. I began with a Bachelor's degree in Biochemistry, but I found myself drawn to the economic and financial sphere. I have collaborated with various organizations, creating articles and blogs about these essential topics. Currently, I cover financial trends, economic updates, and social welfare topics for Polifinus, ensuring that our content reaches those who need it most.

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