FDA Recall D-0527-2025

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, 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.

Lot / code: 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.

Quantity: 20618 bottles

Reason for recall

Failed Impurities/Degradation Specifications.

Recall record

Recall number: D-0527-2025
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.

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