Yale Medicine data in 2024 suggested that 47 million Americans every day take a cholesterol med, often a statin. The U.S. Food and Drug Administration (FDA) has announced a recall on one of the most common statins due to an issue with dosage delivery. The quantity limit on the product is 1,000 with a 2026 expiration date, suggesting daily-dose prescriptions may have been obtained even a couple years ago.

On March 28, the FDA published a nationwide recall for 2,184 bottles of Atorvastatin Calcium Tablets by Biopharmaceutical company Biocon Pharma Inc., for “Failed dissolution specifications: lower than specifications.” These prescription tablets are often referred to by their brand names of Lipitor or Atorvaliq.

The reason for the recall appears to suggest the tablets contain lower amounts of medication than was marketed.

The recalled drug details include:

  • Atorvastatin Calcium Tablets USP, 40 milligrams (mg)
  • 1,000-count bottle
  • Lot #: AVC24035
  • Expiration: 03/31/26
  • Manufactured for: Biocon Pharma Inc., Iselin, NJ
  • Manufactured by: Recipharm Pharmaservices PVT, India

As one of the most commonly prescribed statins, Lipitor works to lower cholesterol and triglycerides levels, as well as the risk of stroke or heart attack. The Mayo Clinic says the medication works by “blocking an enzyme that is needed by the body to make cholesterol, and this reduces the amount of cholesterol in the blood.”

The FDA has labeled the recall as a Class II risk, meaning they’ve determined use of the product “may cause temporary or medically reversible adverse health consequences.” Just last month, a different statin recall occurred due to the “presence of foreign tablets/capsules.”

It may be wise to contact your pharmacist or doctor to ask about replacement medication. The Biocon website also offers a general page for consumers to submit any adverse events, side effects, or product complaints.

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