FDA-Drug2025-07-09Class III

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.

Orient Pharma Co., Ltd. Yunlin Plant
Hazard

Failed Impurities/Degradation Specifications.

Sold states
NJ
Affected count
57504 bottles
Manufactured in
No. 8 Kehu 1st Rd., Huwei Township, Yunlin County, Taiwan
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0526-2025

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief