FDA Recall D-0526-2025

Orient Pharma Co., Ltd. Yunlin Plant

Class III Ongoing 337 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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.

Lot / code: 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.

Quantity: 57504 bottles

Reason for recall

Failed Impurities/Degradation Specifications.

Recall record

Recall number: D-0526-2025
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: NJ
Recall initiated: 2025-06-11
Classified by FDA Center: 2025-07-16
FDA published: 2025-07-09
Recalling firm: Orient Pharma Co., Ltd. Yunlin Plant

Drug identification

Brand name(s): PITAVASTATIN
Generic name(s): PITAVASTATIN CALCIUM
Manufacturer(s): Teva Pharmaceuticals, Inc.
NDC(s): 0480-3631, 0480-3632, 0480-3633
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls