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.

Pantoprazole Sodium for Injection 40mg per vial Recalled by BE PHARMACEUTICALS AG Due to Lack of Assurance of Sterility: Powder discoloration due...

Date: September 5, 2023
Company: BE PHARMACEUTICALS AG
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 BE PHARMACEUTICALS AG directly.

Affected Products

Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distributed by: BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511.

Quantity: 41,148 vials

Why Was This Recalled?

Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About BE PHARMACEUTICALS AG

BE PHARMACEUTICALS AG has 2 total recalls tracked by RecallDetector.

Related Recalls

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