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 Watson Laboratories, Inc.-(Actavis) - Florida Due to Failed Tablet/Capsule Specifications: Split tablets were found in...

Date: December 20, 2013
Company: Watson Laboratories, Inc.-(Actavis) - Florida
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 Watson Laboratories, Inc.-(Actavis) - Florida 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: 5987 bottles

Why Was This Recalled?

Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Watson Laboratories, Inc.-(Actavis) - Florida

Watson Laboratories, Inc.-(Actavis) - Florida has 2 total recalls tracked by RecallDetector.

Related Recalls

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