FDA Drugs recall ·
Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets… recall
- Recall number
- D-0527-2025
- Date
- (initiated June 11, 2025)
- Company / brand
- Orient Pharma Co., Ltd. Yunlin Plant
No. 8 Kehu 1st Rd., Yunlin County, Taiwan - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 20618 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Impurities/Degradation Specifications.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
NJ
States: New Jersey
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0527-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.