Pitavastatin tablets recalled for failed impurities and degradation specifications
Teva Pharmaceuticals is recalling Pitavastatin 2 mg tablets manufactured by Orient Pharma due to failed impurities and degradation specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition indicates the product is unlikely to cause adverse health consequences. No illnesses, injuries, or deaths are reported.
Plain-English summary
Teva Pharmaceuticals is recalling Pitavastatin (Pitavastatin Calcium) 2 mg tablets, 90-tablet bottles (NDC 0480-3632-98 and related package codes), manufactured by Orient Pharma Co., Ltd. Yunlin Plant in Taiwan. The recall affects 57,504 bottles distributed in New Jersey. Specific lot numbers affected are P061001, P061002, P061003, P061004, P061006, P061007, P061008, P061009, P061010, P061011, P061012, P061013, P061016, P061017, P061018, P061019, and P061023, with expiration dates ranging from July 2025 through January 2027.
The recall was initiated due to failed impurities and degradation specifications. This is a Class III recall, indicating that the product is unlikely to cause adverse health consequences.
Consumers who have dispensed or received these affected lots should contact their pharmacy or healthcare provider. Do not use recalled product; return it to the pharmacy or contact Teva Pharmaceuticals for return instructions.
The recalled product
- Product
- PITAVASTATIN (PITAVASTATIN CALCIUM)
- Brand
- PITAVASTATIN
- Manufacturer
- Orient Pharma Co., Ltd. Yunlin Plant
- Category
- Drug — Statin / Cardiovascular
- Affected units
- 57,504
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 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.
UPCs (3)
- 0304803633985
- 0304803631981
- 0304803632988
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Orient Pharma Co., Ltd. Yunlin Plant under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · PITAVASTATIN
- ModerateTeva pitavastatin tablets recalled after failing impurity and degradation specifications
FDA (Drugs) · 2025-07-09
- LowPitavastatin Tablets Recalled for Failed Impurity and Degradation Specifications
FDA (Drugs) · 2025-07-09
- ModeratePitavastatin tablets recalled after failing impurity and degradation specifications
FDA (Drugs) · 2025-07-09
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