Pitavastatin Tablets — Class III drug recall D-0527-2025
Ongoing recall by Orient Pharma Co., Ltd. Yunlin Plant, reported 2025-07-09, distributed in NJ. Failed Impurities/Degradation Specifications.
| Recall number | D-0527-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orient Pharma Co., Ltd. Yunlin Plant, Yunlin County, Taiwan |
| Recall initiated | 2025-06-11 |
| Classified | 2025-07-16 |
| Reported by FDA | 2025-07-09 |
| Distributed | NJ |
| Quantity | 20,618 bottles |
| Reason classes | specification failure |
| NDC | 00480-3631, 00480-3631-98, 00480-3632, 00480-3632-98, 00480-3633, 00480-3633-98 |
| Expiration dates | 2025-07, 2025-10, 2026-01, 2026-07, 2026-09, 2027-01 |
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.
Reason for recall
Failed Impurities/Degradation Specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0527-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.