Class III โ€” Low Risk

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

Ciprofloxacin OPTH 0.3% SOL Recalled by Aidarex Pharmaceuticals LLC Due to Failed Impurities/Degradation Specifications: Out of specification results for...

Date: June 1, 2016
Company: Aidarex 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 Aidarex Pharmaceuticals LLC directly.

Affected Products

Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01

Quantity: 599 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Aidarex Pharmaceuticals LLC

Aidarex Pharmaceuticals LLC has 10 total recalls tracked by RecallDetector.

Related Recalls

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