Pitavastatin Tablets recall
FDA recall D-0526-2025 · initiated Jun 11, 2025
Orient Pharma Co., Ltd. Yunlin Plant recalled Pitavastatin Tablets in Jun 2025 — an FDA Class III recall (D-0526-2025) because Failed Impurities/Degradation Specifications.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradation Specifications.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 57504 bottles
Details
- 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.
- Recalling company
- Orient Pharma Co., Ltd. Yunlin Plant
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- NJ
- Initiated
- Jun 11, 2025
- FDA report date
- Jul 9, 2025
Frequently asked
- Was Pitavastatin Tablets recalled?
- Orient Pharma Co., Ltd. Yunlin Plant recalled Pitavastatin Tablets in Jun 2025 — an FDA Class III recall (D-0526-2025) because Failed Impurities/Degradation Specifications. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Pitavastatin Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0526-2025 was: Failed Impurities/Degradation Specifications.
- Is a recalled Pitavastatin Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Pitavastatin Tablets are affected?
- Distributed: NJ. The recall covers these lots — 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.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0526-2025.