Recall: Two Lots of Atorvastatin Calcium Tablets Contain Foreign Tablets; FDA Classifies the Recall as Class II
According to the U.S. Food and Drug Administration's (FDA) Enforcement Report, MSN Laboratories Private Limited of India has voluntarily recalled two lots of atorvastatin calcium tablets because the product contains foreign tablets or capsules. The FDA posted the recall to its Enforcement Report and classified it as Class II on October 29, under recall number D-0113-2027.
Atorvastatin is a widely prescribed cholesterol-lowering drug. The recalled product is Atorvastatin Calcium Tablets USP, 40 mg, in 1,000-count bottles, for prescription use only, with National Drug Code (NDC) 72205-024-99.
The two affected lots are DRF09618A, expiring August 31, 2029, and DRG02110A, expiring January 31, 2030. Pharmacies and patients can check the lot number printed with the bottle.
The tablets were manufactured by MSN Laboratories at its facility in Telangana, India, and distributed nationwide in the United States by Novadoz Pharmaceuticals LLC of Piscataway, New Jersey. The firm initiated the recall on October 21, 2026, and notified customers by letter.
A Class II classification means use of the product may cause temporary or medically reversible adverse health consequences, while the probability of serious adverse health consequences is remote.
Patients taking atorvastatin should check the lot number on their bottles; anyone whose bottle is from a recalled lot should contact their pharmacy about next steps and should not stop taking a prescribed cholesterol medicine on their own.
FDA recalls and safety alerts page
Source: GSM · USA (original Chinese edition)
Photo: 阿托伐他汀钙片（资料图）。CC BY-SA 4.0，经 Wikimedia Commons。 / Atorvastatin calcium tablets (file photo). CC BY-SA 4.0, via Wikimedia Commons.
