Reported Oct 9, 2024 · Terminated

Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals,…

Nivagen Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Nivagen Pharmaceuticals Inc · 3100 Fite Cir · Sacramento, CA · 95827-1805

Is this the product you have?

  • Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle
  • Manufactured forNivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA
  • Manufactured byUmedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India
  • NDC75834-257-01
Lot codes and dates
  • Lot #: U24T0408A
  • Exp03/31/2026
Amount recalled
2328 bottles

Where it was sold

  • Nationwide

Why it was recalled

Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 1, 2026 · Data as of Sep 19, 8:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.