Reported Sep 29, 2021 · Terminated

Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road…

Glenmark Pharmaceuticals Inc., USA

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: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009

Is this the product you have?

  • Naproxen Sodium Tablets
  • USP 550 mg Rx Only Manufactured byGlenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe
  • NC 28110 Manufactured forGlenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05
Lot codes and dates
  • Lots
    • a) 29190082 Exp. 09/30/2021
    • 29190083 Exp. 09/30/2021
    • 29190084 Exp. 10/31/2021
    • 29190085 Exp. 10/31/2021
    • 29200001 Exp. 12/31/2021
    • 29200003 Exp. 01/31/2022
    • 29200004 Exp. 01/31/2022
    • 29200005 Exp. 01/31/2022
    • 29200012 Exp. 02/28/2022
    • 29200013 Exp. 02/28/2022
    • b) 29200010 Exp. 02/28/2022
Amount recalled
a) 31248 bottles; b) 300 bottles

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 4, 2023 · Data as of Sep 19, 8:06 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.