# FDA recall D-0700-2021

> **Pfizer Inc.** · Class II · drug recall initiated 2021-06-09.

## Product

Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland,  NDC 0069-0471-03.

## Reason for recall

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

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0700-2021
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2021-06-09
- **Report date:** 2021-08-11

- **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-0700-2021

## Citation

> AI Analytics. FDA recall D-0700-2021. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/D-0700-2021. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*