# FDA recall D-0535-2020

> **Sanofi-Aventis U.S. LLC** · Class II · drug recall initiated 2019-10-22.

## Product

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219    NDC's   41167-0300-0,   41167-0300-1,   41167-0300-3,   41167-0300-5,   41167-0300-6,   41167-0300-7,   41167-0300-8

## Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0535-2020
- **Recalling firm:** Sanofi-Aventis U.S. LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2019-10-22
- **Report date:** 2019-12-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0535-2020

## Citation

> AI Analytics. FDA recall D-0535-2020. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/D-0535-2020. Source: US FDA. Licensed CC0.

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