Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Levoleucovorin Injection Recalled by Mylan Institutional Inc Due to Presence of Particulate Matter: particulate matter identified as...

Date: February 1, 2019
Company: Mylan Institutional 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 Mylan Institutional Inc directly.

Affected Products

Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 U.S.A., Made in India. NDC: 67457-601-30

Quantity: 11,964 cartons of 30 vials

Why Was This Recalled?

Presence of Particulate Matter: particulate matter identified as copper salts

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mylan Institutional Inc

Mylan Institutional Inc has 1 total recall tracked by RecallDetector.

Related Recalls

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