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FDAFDA · Food and drugs·Recall number D-0939-2023

Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.

Published July 26, 2023 · Recall initiated: May 1, 2023

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated

Recall details

Brand
FAMOTIDINE
Manufacturer
Glenmark Therapeutics, Inc.
Distributor
Nationwide in the USA
UPC
0372657132015
Lot
FA2022001B, Exp 03/2025
Risk classification
Class II
Area (FDA)
drug
Country
United States

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