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.

Mesalamine Delayed-Release Tablets Recalled by Teva Pharmaceuticals USA Due to Failed Dissolution Specifications: Out-of-specification dissolution results were obtained...

Date: October 28, 2020
Company: Teva Pharmaceuticals USA
Status: Terminated
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 directly.

Affected Products

Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22.

Quantity: 133,829 bottles

Why Was This Recalled?

Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Teva Pharmaceuticals USA

Teva Pharmaceuticals USA has 196 total recalls tracked by RecallDetector.

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