Class IIIReported 2025-07-09

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.

Recalled by Orient Pharma Co., Ltd. Yunlin Plant

Reason for Recall

Failed Impurities/Degradation Specifications.

Recall Number

D-0526-2025

Classification

Class III

Status

Ongoing

Category

drug

Initiated

2025-06-11

Reported

2025-07-09

Distribution

Code Info

P061001, P061002, P061003, P061004, P061006 & P061007 Exp Date 07/2025; P061008, Exp Date 08/2025; P061009 & P061010 Exp Date 10/2025; P061011, P061012 & P061013 Exp Date 01/2026; P061016, P061017 & P061018, Exp Date 04/2026; P061019, Exp Date 05/2026; P061023, Exp Date 01/2027.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.