Class III โ€” Low Risk

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

OXYCODONE HYDROCHLORIDE C II Oral Solution USP Recalled by Boehringer Ingelheim Roxane Inc Due to Failed Stability Specifications: Out of specification result for...

Date: July 28, 2014
Company: Boehringer Ingelheim Roxane 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 Boehringer Ingelheim Roxane Inc directly.

Affected Products

OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.

Quantity: 2,149 Bottles

Why Was This Recalled?

Failed Stability Specifications: Out of specification result for preservative sodium benzoate.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Boehringer Ingelheim Roxane Inc

Boehringer Ingelheim Roxane Inc has 15 total recalls tracked by RecallDetector.

Related Recalls

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