Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Irbesartan Tablets USP Recalled by AvKARE Due to Out of Specification for Dissolution

Date: January 21, 2025
Company: AvKARE
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact AvKARE directly.

Affected Products

Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15

Quantity: 341 cartons

Why Was This Recalled?

Out of Specification for Dissolution

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About AvKARE

AvKARE has 20 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report