Medications & Supplements/Prescription Drugs

Pitavastatin Tablets Recalled for Failed Impurity and Degradation Specifications

Agency Publication Date: July 16, 2025

Summary

AvKARE is recalling approximately 10,133 bottles of Pitavastatin tablets (1 mg and 2 mg) because the products failed to meet specifications for impurities and degradation. This recall affects 90-count prescription bottles manufactured for AvKARE. Consumers using this medication should speak with their doctor or pharmacist to discuss continuing their treatment or obtaining a replacement.

Risk

The tablets may contain levels of impurities or degraded ingredients that exceed approved safety limits. This could potentially reduce the effectiveness of the medication or lead to unexpected side effects over long-term use.

What You Should Do

This recall affects Pitavastatin Tablets in 1 mg and 2 mg strengths sold in 90-count bottles under the AvKARE brand with NDC codes 42291-905-90 or 42291-906-90.
For the 1 mg strength, check your bottle for lot numbers 46208 (Exp 10/31/2025), 47738 (Exp 09/30/2026), or 46943 (Exp 05/31/2026).
For the 2 mg strength, check your bottle for lot numbers 46211 (Exp 10/31/2025), 47683 (Exp 05/31/2026), or 46944 (Exp 01/31/2026).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Pitavastatin Tablets (1 mg)by AvKARE

Variants: 1 mg, 90 Tablets per bottle, Rx Only

Lot Numbers:

46208 (Exp 10/31/2025)

47738 (Exp 09/30/2026)

46943 (Exp 05/31/2026)

NDC:

42291-905-90

Manufactured for: AvKARE, Pulaski, TN 38478.

Product: Pitavastatin Tablets (2 mg)by AvKARE

Variants: 2 mg, 90 Tablets per bottle, Rx Only

Lot Numbers:

46211 (Exp 10/31/2025)

47683 (Exp 05/31/2026)

46944 (Exp 01/31/2026)

NDC:

42291-906-90

Manufactured for: AvKARE, Pulaski, TN 38478.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97160

Status: Active

Manufacturer: AvKARE

Manufactured In: United States

Units Affected: 2 products (1,560 bottles; 8,573 bottles)

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Pitavastatin Tablets in 1 mg and 2 mg strengths sold in 90-count bottles under the AvKARE brand with NDC codes 42291-905-90 or 42291-906-90.

For the 1 mg strength, check your bottle for lot numbers 46208 (Exp 10/31/2025), 47738 (Exp 09/30/2026), or 46943 (Exp 05/31/2026).

For the 2 mg strength, check your bottle for lot numbers 46211 (Exp 10/31/2025), 47683 (Exp 05/31/2026), or 46944 (Exp 01/31/2026).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Pitavastatin Tablets (1 mg)by AvKARE

Variants: 1 mg, 90 Tablets per bottle, Rx Only

Lot Numbers:

46208 (Exp 10/31/2025)

47738 (Exp 09/30/2026)

46943 (Exp 05/31/2026)

NDC:

42291-905-90

Manufactured for: AvKARE, Pulaski, TN 38478.

Product: Pitavastatin Tablets (2 mg)by AvKARE

Variants: 2 mg, 90 Tablets per bottle, Rx Only

Lot Numbers:

46211 (Exp 10/31/2025)

47683 (Exp 05/31/2026)

46944 (Exp 01/31/2026)

NDC:

42291-906-90

Manufactured for: AvKARE, Pulaski, TN 38478.