Class IIIReported 2025-07-09

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.

Recalled by Orient Pharma Co., Ltd. Yunlin Plant

Reason for Recall

Failed Impurities/Degradation Specifications.

Recall Number

D-0527-2025

Classification

Class III

Status

Ongoing

Category

drug

Initiated

2025-06-11

Reported

2025-07-09

Distribution

NJ

Code Info

P051001, P051002, & P051003, Exp Date 07/2025; P051005, Exp Date 10/2025; P051006, Exp Date 10/2025; P051007, Exp Date 01/2026; P051010, Exp Date 07/2026; P051011 & P051012, Exp Date 09/2026; P051013, P051014 and P051015, Exp Date 01/2027.

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