Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

1% Lidocaine HCl Injection Recalled by PFIZER, INC Due to Labeling: Label Mix-Up: some vials labeled to contain...

Date: May 3, 2021
Company: PFIZER, INC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact PFIZER, INC directly.

Affected Products

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.

Quantity: 139,050 vials

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About PFIZER, INC

PFIZER, INC has 2 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report