# FDA recall D-0939-2023

> **Glenmark Therapeutics, Inc.** · Class II · drug recall initiated 2023-05-01.

## Product

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.

## Reason for recall

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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0939-2023
- **Recalling firm:** Glenmark Therapeutics, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-05-01
- **Report date:** 2023-07-26
- **Termination date:** 2024-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0939-2023

## Citation

> AI Analytics. FDA recall D-0939-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0939-2023. Source: US FDA. Licensed CC0.

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