# FDA recall D-0627-2021

> **PFIZER, INC** · Class I · drug recall initiated 2021-05-03.

## Product

1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.

## Reason for recall

Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP

## Distribution

Nationwide in the USA, Puerto Rico, and Guam

## Key facts

- **Recall number:** D-0627-2021
- **Recalling firm:** PFIZER, INC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-05-03
- **Report date:** 2021-06-09
- **Termination date:** 2023-04-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0627-2021

## Citation

> AI Analytics. FDA recall D-0627-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0627-2021. Source: US FDA. Licensed CC0.

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