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.

Budesonide Extended-Release Tablets 9mg Recalled by Teva Pharmaceuticals USA, Inc Due to Failed Dissolution Specifications

Date: January 8, 2024
Company: Teva Pharmaceuticals USA, Inc
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 Teva Pharmaceuticals USA, Inc directly.

Affected Products

Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30

Quantity: 10,672 30-count bottles

Why Was This Recalled?

Failed Dissolution Specifications

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Teva Pharmaceuticals USA, Inc

Teva Pharmaceuticals USA, Inc has 20 total recalls tracked by RecallDetector.

Related Recalls

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