Orient Pharma Co., Ltd. Yunlin Plant recalls Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen,…

Recall date

June 11, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0527-2025

FDA classification

Class III

Brand / firm

Orient Pharma Co., Ltd. Yunlin Plant

Sold / distributed

NJ

Why it was recalled

Failed Impurities/Degradation Specifications.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Pitavastatin Tablets, 1 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 0480-3631-98.