Reported Jan 15, 2020 · Ongoing

Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd.…

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?

  • Glenmark Ranitidine Tablets USP 300
  • mg Rx Only 250 Tablets Manufactured byGlenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513
  • India Manufactured forGlenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20
Lot codes and dates
  • 138 of 138 codes

    • 7701069A
    • 7701070A
    • 7701084A
    • 7701085A
    • 7701087A
    • 7701094A
    • 7701095A
    • 7701140A
    • 7701141A
    • 7701142A
    • 7701157A
    • 7701162A
    • 7701182A
    • 7701217A
    • 7701218A
    • 7701219A
    • 7701236A
    • 7701237A
    • 7701220A
    • 7701456A
    • 7701470A
    • 7701520A
    • 7701671A
    • 7701696A
    • 7701697A
    • 7701698A
    • 7701797A
    • 7701928A
    • 7701929A
    • 7701942A
    • 7701943A
    • 7702065A
    • 7702066A
    • 7702067A
    • 7702095A
    • 7702096A
    • 7702097A
    • 7702098A
    • 7702188A
    • 7702189A
    • 7702190A
    • 7702196A
    • 7702197A
    • 7702198A
    • 7702199A
    • 7702348A
    • 7702338A
    • 7702347A
    • 7702349A
    • 7702350A
    • 7702391A
    • 7702392A
    • 7702546A
    • 7702547A
    • 7702548A
    • 7702616A
    • 7702617A
    • 7702618A
    • 7702619A
    • 7702620A
Amount recalled
500,960 bottles

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Why it was recalled

CGMP Deviations: Presence of NDMA impurity detected in product.

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

Data as of Sep 19, 6:29 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.