Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Duloxetine Delayed-Release Capsules Recalled by Apotex Scientific, Inc Due to Failed Dissolution Specification: Out of specification dissolution results...

Date: January 26, 2016
Company: Apotex Scientific, 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 Apotex Scientific, Inc directly.

Affected Products

Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;

Quantity: 107,880 (60 ct bottle)

Why Was This Recalled?

Failed Dissolution Specification: Out of specification dissolution results when testing product stability.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Apotex Scientific, Inc

Apotex Scientific, Inc has 3 total recalls tracked by RecallDetector.

Related Recalls

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