# FDA recall D-0251-2021

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class III · drug recall initiated 2021-02-05.

## Product

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

## Reason for recall

Failed Impurity/Degradation Specifications

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0251-2021
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-02-05
- **Report date:** 2021-02-17
- **Termination date:** 2021-11-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0251-2021

## Citation

> AI Analytics. FDA recall D-0251-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0251-2021. Source: US FDA. Licensed CC0.

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