# FDA recall D-0809-2021

> **Pfizer Inc.** · Class II · drug recall initiated 2021-08-13.

## Product

Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only,  Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0468-56.

## Reason for recall

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0809-2021
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2021-08-13
- **Report date:** 2021-09-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0809-2021

## Citation

> AI Analytics. FDA recall D-0809-2021. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0809-2021. Source: US FDA. Licensed CC0.

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