# FDA recall D-0658-2025

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2025-09-03.

## Product

Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1

## Reason for recall

Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0658-2025
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-09-03
- **Report date:** 2025-09-24

- **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-0658-2025

## Citation

> AI Analytics. FDA recall D-0658-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0658-2025. Source: US FDA. Licensed CC0.

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