Reported Mar 25, 2020 · Terminated

Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries…

Sun Pharmaceutical Industries, 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: Sun Pharmaceutical Industries, Inc. · 270 Prospect Plains Rd · Cranbury, NJ · 08512-3605

Is this the product you have?

  • Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle
  • Manufactured bySun Pharmaceutical Industries Limited Mohali, INDIA
  • Distributed bySun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05
Lot codes and dates
    • Lot#: AA33617
    • Exp 03/2021
Amount recalled
1416 bottles

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

Presence of foreign substance: Foreign matter has been identified as latex glove in one lot 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 Feb 9, 2021 · Data as of Sep 19, 5:04 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.