Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Is Leucovorin recalled?
Not under an active recall.
Leucovorin was recalled 16 times in the past — all now closed. Most recent: Jul 29, 2021.
Most common reason: Sterility / contamination (9 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Leucovorin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Leucovorin recalls on record
none so far in 2026; 16 on record, newest first
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin 15mg 24
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class III · Low risk
Leucovorin Calcium Tablets USP
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Class II · Moderate risk
Leucovorin Calcium Injection
Crystallization: Presence of particulate matter identified as API crystallization
Class II · Moderate risk
Leucovorin 560 Mg / 250 Ml Ns Ivpb
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin Calcium USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Leucovorin Calcium capsules
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Leucovorin 1 mg/1 mL Susp
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Leucovorin Calcium active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Leucovorin Calcium Injection USP
Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
Class II · Moderate risk
Leucovorin
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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