Agency classClass IIIOur severity:Low FDA (Drugs)·D-0529-2025·Announced 2025-07-09

Pitavastatin Tablets Recalled for Failed Impurity and Degradation Specifications

AvKARE is recalling Pitavastatin 2 mg tablets nationwide due to failed impurity and degradation specifications. The affected lots do not meet quality standards for chemical purity.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall involving a labeling or manufacturing defect where the hazard is theoretical and no illnesses or injuries have been reported. Class III recalls are by definition unlikely to cause adverse health consequences.

Plain-English summary

AvKARE is recalling Pitavastatin Tablets, 2 mg (90 tablets per bottle), manufactured for AvKARE in Pulaski, Tennessee. The recall affects three lots: Lot 46211 (expiration 10/31/2025), Lot 47683 (expiration 05/31/2026), and Lot 46944 (expiration 01/31/2026), representing approximately 8,573 bottles distributed nationwide in the USA.

The recall is due to failed impurity and degradation specifications, meaning the tablets do not meet established quality standards for chemical purity and stability. Pitavastatin is a prescription medication used to lower cholesterol.

Patients currently taking Pitavastatin from the affected lots should contact their pharmacist or healthcare provider. Do not stop taking the medication without medical guidance. Healthcare providers and pharmacists should quarantine and return affected inventory to AvKARE.

The recalled product

Product: PITAVASTATIN (PITAVASTATIN CALCIUM)
Brand: PITAVASTATIN
Manufacturer: AvKARE
Category: Drug — Prescription - Statin
Hazard: impurity
degradation
quality-control
Affected units: 8,573

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 (7)

Lot
expiry: Lot 46211
exp 10/31/2025
Lot 47683
exp 05/31/2026
Lot 46944
exp 01/31/2026

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by AvKARE 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 →

Same brand · PITAVASTATIN

Low
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FDA (Drugs) · 2025-07-09
Moderate
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FDA (Drugs) · 2025-07-09
Moderate
Pitavastatin tablets recalled after failing impurity and degradation specifications
FDA (Drugs) · 2025-07-09

Same manufacturer · AvKARE

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Same hazard · impurity