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.

Leucovorin Calcium Injection Recalled by Ingenus Pharmaceuticals Llc Due to Crystallization: Presence of particulate matter identified as API...

Date: October 9, 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

Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839

Quantity: 16485 vials

Why Was This Recalled?

Crystallization: Presence of particulate matter identified as API crystallization

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