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.

Rifampin for Injection Recalled by Mylan Laboratories Limited (Sterile Products Division) Due to Failed Impurities/Degradation Specifications: discoloration due to elevated unknown...

Date: October 7, 2019
Company: Mylan Laboratories Limited (Sterile Products Division)
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 Mylan Laboratories Limited (Sterile Products Division) directly.

Affected Products

Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.

Quantity: 19,165 vials

Why Was This Recalled?

Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mylan Laboratories Limited (Sterile Products Division)

Mylan Laboratories Limited (Sterile Products Division) has 1 total recall tracked by RecallDetector.

Related Recalls

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