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.

Bupivacaine HCl Inj. Recalled by Hospira Inc. Due to Presence of Particulate Matter: A confirmed customer complaint...

Date: September 4, 2014
Company: Hospira 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 Hospira Inc. directly.

Affected Products

Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1162-02

Quantity: 75,000 vials

Why Was This Recalled?

Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Hospira Inc.

Hospira Inc. has 245 total recalls tracked by RecallDetector.

Related Recalls

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