Teva pitavastatin tablets recalled after failing impurity and degradation specifications
Pitavastatin Tablets 1 mg manufactured by Orient Pharma for Teva Pharmaceuticals are being recalled because they failed impurities and degradation specifications. 20,618 bottles affected.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall for an out-of-specification impurity result with no named impurity, measured level or health consequence stated.
Plain-English summary
Pitavastatin Tablets, 1 mg, 90 tablets per bottle, prescription only, manufactured by Orient Pharma Co., Ltd. of Yunlin, Taiwan for Teva Pharmaceuticals of Parsippany, New Jersey, are being recalled. The action covers 20,618 bottles.
The stated reason is that the product failed impurities and degradation specifications. The FDA classified the action as Class III, its least serious classification. The source does not name the impurity or state a measured level.
Affected lots include P051001, P051002 and P051003 expiring 07/2025, P051005 expiring 10/2025 and P051006, together with the further lots listed in the recall notice. Distribution was in New Jersey.
Patients holding affected lots should speak to their pharmacist before stopping treatment, and pharmacies should follow the instructions issued by the manufacturer.
The recalled product
- Product
- PITAVASTATIN (PITAVASTATIN CALCIUM)
- Brand
- PITAVASTATIN
- Manufacturer
- Orient Pharma Co., Ltd. Yunlin Plant
- Category
- Drug — Oral tablet
- Affected units
- 20,618
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 (16)
- P051001
- P051002
- & P051003
- Exp Date 07/2025
- P051005
- Exp Date 10/2025
- P051006
- P051007
- Exp Date 01/2026
- P051010
- Exp Date 07/2026
- P051011 & P051012
- Exp Date 09/2026
- P051013
- P051014 and P051015
- 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
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