# FDA recall D-0526-2025

> **Orient Pharma Co., Ltd. Yunlin Plant** · Class III · drug recall initiated 2025-06-11.

## Product

Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3632-98.

## Reason for recall

Failed Impurities/Degradation Specifications.

## Distribution

NJ

## Key facts

- **Recall number:** D-0526-2025
- **Recalling firm:** Orient Pharma Co., Ltd. Yunlin Plant
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-06-11
- **Report date:** 2025-07-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Yunlin County, Taiwan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0526-2025

## Citation

> AI Analytics. FDA recall D-0526-2025. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/D-0526-2025. Source: US FDA. Licensed CC0.

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