Class III โ€” Low Risk

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

Diclofenac Sodium Topical Solution Recalled by Ingenus Pharmaceuticals Llc Due to Defective Container: firm discovered samples stored horizontally as...

Date: March 18, 2019
Company: Ingenus Pharmaceuticals Llc
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 Ingenus Pharmaceuticals Llc directly.

Affected Products

Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.

Quantity: 29,435 bottles

Why Was This Recalled?

Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ingenus Pharmaceuticals Llc

Ingenus Pharmaceuticals Llc has 6 total recalls tracked by RecallDetector.

Related Recalls

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