Leucovorin Calcium Injection (Ingenus) – Crystallization Risk (2019)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Ingenus Pharmaceuticals Llc
Lot Codes / Batch Numbers
Lot#: 18048, 18049 Exp. 04/2020, 18050 Exp 05/2020, 19036 Exp 12/2020
Products Sold
Lot#: 18048, 18049 Exp. 04/2020; 18050 Exp 05/2020; 19036 Exp 12/2020
Ingenus Pharmaceuticals Llc is recalling Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 R due to Crystallization: Presence of particulate matter identified as API crystallization. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Crystallization: Presence of particulate matter identified as API crystallization
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026