Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Labetalol Hydrochloride Injection Recalled by Hospira Inc. A Pfizer Company Due to Defective Container: Cracked glass at the rim surface...

Date: February 20, 2018
Company: Hospira Inc. A Pfizer Company
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 Hospira Inc. A Pfizer Company directly.

Affected Products

Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-25.

Quantity: a) 137,975 vials; b) 40,143 vials

Why Was This Recalled?

Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Hospira Inc. A Pfizer Company

Hospira Inc. A Pfizer Company has 1 total recall tracked by RecallDetector.

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