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 Impurity/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, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
Affected NDC
42291-0906-90
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 42291-0906 |
2.09 mg/1 | Tablet, Film Coated Oral |
AvKARE | Rx |
- Recalling firm
- AvKARE
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0529-2025 · 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
See all
Class III · Low risk
Pitavastatin Tablets
Failed Impurity/Degradation Specifications
Class III · Low risk
Pitavastatin Tablets
Failed Impurities/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 AvKARE
All 2025 recalls
Class II · Moderate risk
Amantadine HCl
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Class II · Moderate risk
Rosuvastatin Tablets
Out of specification for dissolution.
Class II · Moderate risk
Norgestimate and Ethinyl Estradiol Tablets
Failed Content Uniformity Specifications
Class II · Moderate risk
chloroproMAZINE Hydrochloride Tablets
Presence of a foreign substance.
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