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.

Duloxetine Delayed-Release Cap USP 30mg Recalled by Preferred Pharmaceuticals, Inc. Due to CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA...

Date: May 10, 2024
Company: Preferred Pharmaceuticals, 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 Preferred Pharmaceuticals, Inc. directly.

Affected Products

Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03

Quantity: 66 bottles of 30 tablets

Why Was This Recalled?

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Where Was This Sold?

This product was distributed to 5 states: CA, CT, FL, KS, OK

Affected (5 states)Not affected

About Preferred Pharmaceuticals, Inc.

Preferred Pharmaceuticals, Inc. has 44 total recalls tracked by RecallDetector.

Related Recalls

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