# FDA recall D-0539-2020

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

## Product

Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219.    NDC's:   0597-0121-01,   0597-0121-06,   0597-0121-08,   0597-0121-09,   0597-0121-11,   0597-0121-24,   0597-0121-38,   0597-0121-50,   0597-0121-64,   0597-0121-66,   0597-0121-68,   0597-0121-78,   0597-0121-80,   0597-0121-82,   0597-0121-85,   0597-0121-90,   0597-0121-94.

## Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0539-2020
- **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-0539-2020

## Citation

> AI Analytics. FDA recall D-0539-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0539-2020. Source: US FDA. Licensed CC0.

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