Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed Recalled by SUN PHARMACEUTICAL INDUSTRIES INC Due to Failed Impurity/Degradation Specifications

Date: February 5, 2021
Company: SUN PHARMACEUTICAL INDUSTRIES 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 SUN PHARMACEUTICAL INDUSTRIES INC directly.

Affected Products

Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 62756-129-40

Quantity: 20,475 vials

Why Was This Recalled?

Failed Impurity/Degradation Specifications

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About SUN PHARMACEUTICAL INDUSTRIES INC

SUN PHARMACEUTICAL INDUSTRIES INC has 86 total recalls tracked by RecallDetector.

Related Recalls

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