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.

Diclofenac Sodium and Misoprostol Delayed-Release Tablets Recalled by Actavis Laboratories, FL, Inc. Due to Failed Tablet/Capsule Specifications: Presence of split or broken...

Date: September 26, 2014
Company: Actavis Laboratories, FL, Inc.
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 Actavis Laboratories, FL, Inc. directly.

Affected Products

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC: 0591-0398-60, UPC 3 05910 39860 6.

Quantity: 5,451 Bottles

Why Was This Recalled?

Failed Tablet/Capsule Specifications: Presence of split or broken tablets.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Actavis Laboratories, FL, Inc.

Actavis Laboratories, FL, Inc. has 7 total recalls tracked by RecallDetector.

Related Recalls

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