FDAFDA · Food and drugs·Recall number D-0526-2025
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.
Published July 9, 2025 · Recall initiated: June 11, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PITAVASTATIN
- Manufacturer
- Orient Pharma Co., Ltd. Yunlin Plant
- Distributor
- NJ
- UPC
- 0304803633985
- Lot
- 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.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- Taiwan
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.