Cholesterol Medication Recalled: Over 140,000 Bottles Affected

This article used AI tools to compile recall data. An AARP editor reviewed and refined the content for accuracy and clarity.

Several lots of atorvastatin calcium tablets, a widely used cholesterol-lowering medication, have been recalled because the pills may not dissolve properly in the body, potentially reducing their effectiveness, the Food and Drug Administration (FDA) announced.

The agency cited “failed dissolution specifications” as the reason for the recall, meaning when the pill is swallowed, it may not break down at the right speed to be absorbed by the body. If it dissolves too slowly or unevenly, you might not get the full benefit — even if you take the correct dose.

The FDA classified the recall as a Class II, meaning the products could cause temporary or medically reversible health problems.

Which statins are recalled?

The recalled batches of atorvastatin calcium, the generic version of Lipitor, were manufactured by Alkem Laboratories, Ltd. of India and distributed by Ascend Laboratories of New Jersey. The following lots were affected:

Atorvastatin Calcium Tablets USP, 10 mg

• Recall number: D-0017-2026
• Lot numbers and expiration dates:
  • 25141249 (February 2027)
  • 24144938, 24144868, 24144867 (November 2026)​• 24144458, 24143994 (September 2026)​• 24142987, 24143316 (July 2026)

Atorvastatin Calcium Tablets USP, 20 mg

• Recall number: D-0019-2026
• Lot numbers:
  • Multiple lots expiring August through December 2026

Atorvastatin Calcium Tablets USP, 40 mg

• Recall number: D-0018-2026
• Lot numbers and expiration dates:
  • 25140933 (February 2027) ​
  • 25140477 (December 2026)
  • 24144254 (October 2026)
  • 24144163, 24143995 (September 2026)

Atorvastatin Calcium Tablets USP, 80 mg

• Recall number: D-0020-2026
• Lot numbers and expiration dates:
  • 25140249, 25140247 (December 2026)
  • 24144999, 24144942, 24144845, 24144713 (November 2026)
  • 24144652 (October 2026)
  • 24143898, 24143412, 24143582 (August 2026)

For the full list of affected lots, see the recall report.

What should patients do?

Do not stop taking your medication without first consulting your doctor. Suddenly discontinuing statins can raise your risk of heart attack or stroke.

For Class II and III recalls, the FDA notes that patients can usually continue taking their medication unless the manufacturer provides different instructions. In some cases, stopping treatment may pose a greater risk than continuing to use the recalled product.

If your medication is affected:

• Contact your doctor or pharmacist for specific guidance.
• Report any side effects or quality issues through the FDA’s MedWatch Adverse Event Reporting Program.