Reported Jan 15, 2020 · Ongoing

Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 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 100 Tablets Manufactured byGlenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513
  • India Manufactured forGlenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01
Lot codes and dates
  • 144 of 144 codes

    • 7701030A
    • 7701031A
    • 7701062A
    • 7701063A
    • 7701110A
    • 7701111A
    • 7701112A
    • 7701185A
    • 7701186A
    • 7701187A
    • 7701188A
    • 7701189A
    • 7701269A
    • 7701270A
    • 7701278A
    • 7701279A
    • 7701386A
    • 7701400A
    • 7701401A
    • 7701406A
    • 7701421A
    • 7701434A
    • 7701435A
    • 7701436A
    • 7701452A
    • 7701453A
    • 7701521A
    • 7701522B
    • 7701553A
    • 7701554A
    • 7701555A
    • 7701556A
    • 7701582A
    • 7701817A
    • 7701828A
    • 7701829A
    • 7702001A
    • 7702002A
    • 7702003A
    • 7702012A
    • 7702026A
    • 7702027A
    • 7702064A
    • 7702140A
    • 7702253A
    • 7702254A
    • 7702285A
    • 7702286A
    • 7702287A
    • 7702288A
    • 7702294A
    • 7702413A
    • 7702462A
    • 7702491A
    • 7702492A
    • 7702504A
    • 7702505A
    • 7702515A
    • 7702698A
    • 7702699A
Amount recalled
1,309,536 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, 6:35 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.