Reported Jul 26, 2023 · Terminated

Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA,…

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

Is this the product you have?

  • Famotidine Tablets, USP, 20mg, 200-count bottle within a carton
  • Distributed byGlenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20
Lot codes and dates
    • FA2022001B
    • Exp 03/2025
Amount recalled
19,968 bottles

Where it was sold

  • Nationwide

Why it was recalled

Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 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 Sep 17, 2024 · Data as of Sep 19, 6:39 PM UTC

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