Ingenus Pharmaceuticals Leucovorin Calcium Injection Recall

Why it was recalled

Crystallization: Presence of particulate matter identified as API crystallization

Product description

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

Lot numbers, UPCs & expiration codes

Lot#: 18048, 18049 Exp. 04/2020; 18050 Exp 05/2020; 19036 Exp 12/2020

Where it was sold

U.S.A. Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0146-2020
Classification: Class II
Status: Terminated
Recall initiated: Oct 9, 2019
FDA report date: Oct 23, 2019
Quantity: 16485 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Ingenus Pharmaceuticals Llc

Original FDA data

Every field from FDA enforcement report D-0146-2020, exactly as published.

Show all FDA fields

City: Orlando
State: FL
Status: Terminated
Country: United States
Event ID: 84011
Address: 4190 Millenia Blvd
Code information: Lot#: 18048, 18049 Exp. 04/2020; 18050 Exp 05/2020; 19036 Exp 12/2020
Postal code: 32839-6408
Report date: Oct 23, 2019
Product type: Drugs
Recall number: D-0146-2020
Classification: Class II
Recalling firm: Ingenus Pharmaceuticals Llc
Product quantity: 16485 vials
Termination date: Dec 1, 2020
Reason for recall: Crystallization: Presence of particulate matter identified as API crystallization
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: U.S.A. Nationwide
Recall initiation date: Oct 9, 2019
Initial firm notification: Letter
Center classification date: Oct 17, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0146-2020, published Oct 23, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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