Class III · Low risk
Pitavastatin Tablets
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Pitavastatin Tablets (Pitavastatin Calcium)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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.
Affected NDC
0480-3631-98
Compare with the code on your package — it is the most precise check available.
Drug: Pitavastatin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Pitavastatin pitavastatin calcium NDC 00480-3631 |
1.045 mg/1 | Tablet, Film Coated Oral |
Teva Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Orient Pharma Co., Ltd. Yunlin Plant
- NDC code
- 0480-3631-98
- Origin
- Taiwan
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0527-2025 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Pitavastatin recalls
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Class III · Low risk
Pitavastatin Tablets
Failed Impurity/Degradation Specifications
Class III · Low risk
Pitavastatin Tablets
Failed Impurity/Degradation Specifications
Class III · Low risk
Pitavastatin Tablets
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Livalo (pitavastatin)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Orient Pharma Co., Ltd. Yunlin Plant
All 2025 recalls
Class III · Low risk
Pitavastatin Tablets
Failed Impurities/Degradation Specifications.
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