CLASS II Drug recall · Reported 21 Aug 2019 · FDA Enforcement Report

Leucovorin 560 MG / Ns Ivpb recalled by Infusion Options

Infusion Options is recalling Leucovorin 560 MG / Ns Ivpb, distributed in New York. The recall was initiated on 12 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots within expiry
Quantity recalledN/A

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-1789-2019
FDA event ID
83136
Recalling firm
Infusion Options, Brooklyn, NY
Classification
Class II
Status
Terminated
Recall initiated
12 Jun 2019
FDA classified
15 Aug 2019
Reported
21 Aug 2019
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

12 Jun 2019Recall initiated by company
15 Aug 2019Classified by FDA+64 days
21 Aug 2019Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

LEUCOVORIN 560 MG / 250 ML NS IVPB; LEUCOVORIN 830 MG / 250 ml NS IVPB; LEUCOVORIN 300 MG / 50 ml D5W IVPB; LEUCOVORIN 840 MG / 250 ml NS IVPB; LEUCOVORIN 750 MG / 250 ml NS IVPB; LEUCOVORIN 690 MG / 250 ml NS IVPB; LEUCOVORIN 314 mg / 50 ml NS IVPB; LEUCOVORIN 620 MG / 250 ml D5W IVPB; LEUCOVORIN 420 MG / 50 ML D5W IVPB; LEUCOVORIN 700 MG / 250 ml D5W IVPB; LEUCOVORIN 592 mg / 250 ml D5W IVPB; LEUCOVORIN 760 mg / 250 ml D5W IVPB; LEUCOVORIN 796 MG / 250 ml D5W IVPB; LEUCOVORIN 730 MG / 250 ml D5W IVPB; LEUCOVORIN 324 mg / 50 ml NS IVPB; LEUCOVORIN 590 MG / 250 ml D5W IVPB; LEUCOVORIN 336 MG / 50 ml NS IVPB; LEUCOVORIN 398 MG/ 250 ml D5W IVPB; LEUCOVORIN 354 MG / 50 ml NS IVPB; LEUCOVORIN 720 MG / 250 ml D5W IVPB; LEUC; VORIN 328 mg / 50 ml NS IVPB; LEUCOVORIN 776 MG / 250 ml D5W IVPB; LEUCOVORIN 339 MG / 250 ml D5W IVPB; LEUCOVORIN 800 mg / 250 ml D5W IVPB; LEUCOVORIN 330 MG / 50 ml D5W IVPB; LEUCOVORIN 330 MG / 50 ml NS IVPB; LEUCOVORIN 688 MG in 250 ML D5W IVPB; LEUCOVORIN 350 MG / 250 ml NS IVPB; LEUCOVORIN 672 MG / 250 ml D5W IVPB; LEUCOVORIN 588 mg / 250 ml D5W IVPB; LEUCOVORIN 812 MG / 250 ML D5W IVPB; LEUCOVORIN 300 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Where it was distributed

NY only

New York

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

All lots within expiry

Where was it sold?

NY only

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

75 other products · FDA event 83136

This product is part of a recall event; the main page for the event is Injectafer 720 MG in NS Ivpb recalled by Infusion Options.

ReportedClassRecallCompanyReasonWhere
CLASS IIInjectafer 720 MG in NS Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIAdcetris 96 MG/ NS IVPB recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIDiphenhydramine 25 MG/ Ns recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIDocetaxel 60 MG / D5w Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IITopotecan 1.24 MG / Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIFerric Carboxymaltose 750mg/ NS Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIFluorouracil 560 MG / IVP Fluorouracil 3340 MG QS 0.9% NACL recalledInfusion OptionsSterilityNY
CLASS IICisplatin 40 MG / NS Ivpb With Mannitol recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIGazyva 100 MG In Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIGemcitabine 1910 MG / NS IVPB recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIHerceptin 400 MG / Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIAbraxane 170 MG / IVPB recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIVelcade 2.1 mg / SQ Syringe recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IISoliris 1200 MG Qs Nacl0.9% Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IITrastuzumab 427 MG / Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIInFLIXimab 300 mg / 0.9% Nacl Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIOpdivo 200 mg / NS VPB recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIPaclitaxel 258 MG / Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIAvastin 630 MG / 0.9% Nacl Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIPerjeta 420 MG/ 0.9% Nacl Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIIrinotecan 250 MG / D5w Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIGranisetron 1000 MCG / Ns recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIVincristine 1 MG / Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IICytarabine 128 MG/ D5W IVPB recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IICyclophosphamide 840 MG / NS IVPB recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIAdo-trastuzumab 210 MG/ Ns; Ado-trastuzumab E 213 MG / Ns recalledInfusion OptionsSterilityNY
CLASS IIAtezolizumab 1200 MG / 0.9% Nacl recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIPaclitaxel Protein 175 MG/ Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIPreservative Free 0.9% Nacl Syr recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IICarfilzomib 65 MG In D5w Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIPemetrexed 910 MG Qs Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIBevacizumab 784 MG / Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIEtoposide 184 MG / NS IVPB recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIEntyvio 300 MG / 0.9% Nacl recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIRemicade 680 MG Qs 0.9% Nacl Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIMethotrexate 25 MG / Im Syr recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IISodium Chloride 0.9% WITH Potassium Chloride 20 mEq recalledInfusion OptionsSterilityNY
CLASS IIDexamethasone 10 MG / Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIDacarbazine 680 MG in NS; Dacarbazine 675 MG in NS recalledInfusion OptionsSterilityNY
CLASS IICisplatin 40 MG / NS Ivpb With Mannitol recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIRamucirumab 457 MG Qs Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIIfosfamide 9200 MG / Ns Ivpb With Mesna 9200 MG recalledInfusion OptionsSterilityNY
CLASS IIDoxorubicin 110 MG / IVP Syringe recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIPaclitaxel Albumin 185 mg / NS Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIDurvalumab 651 mg/ NS IVPB recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIIron Sucrose 200 mg / NS Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIBortezomib 2.5 mg / SQ Syringe recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIRituxan 728 MG Qs 0.9% Nacl Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIDoxorubicin Liposomal 71 MG / D5W IVPB recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIErbitux 770 MG/ Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIMethylprednisolone 10 MG / Ivp recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIVinblastine 10.9 MG / D5w Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIDaratumumab 904 MG Qs Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIAlimta 785 mg QS 0.9% Nacl Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIPertuzumab 840 MG/250 ml0.9% Nacl Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIFosaprepitant 150 mg/ NS Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIOndansetron 8 MG / Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIMitomycin 10 MG / Ivp Syringe recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIBleomycin Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIRomiPLOStim 700 MCG/ SQ SYR recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IINivolumab 480 MG / Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIAzacitidine 125 MG / Sub-q Syringe recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIRituximab 575 MG / 0.9% Nacl Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIOrencia 750 mg QS 0.9% Nacl Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIPanitumumab 400 MG / Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIDarzalex 1008 MG / Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIOxytocin Lactated Ringers Intravenous Solution recalledInfusion OptionsSterilityNY
CLASS IICarboplatin 174 MG / Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIFluorouracil 560 MG / IVP recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIDecitabine 40 MG / Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIEribulin 1.12 MG / Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IICetuximab 335 MG / Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIOxaliplatin 145 MG / D5w Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IICalcium Gluconate 1 Gm / Nacl 0.9% Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
CLASS IIPembrolizumab 200 MG / Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY

More recalls from Infusion Options

All 76
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIPembrolizumab 200 MG / Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
DrugCLASS IICalcium Gluconate 1 Gm / Nacl 0.9% Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
DrugCLASS IIOxaliplatin 145 MG / D5w Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
DrugCLASS IICetuximab 335 MG / Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY
DrugCLASS IIEribulin 1.12 MG / Ns Ivpb recalled by Infusion OptionsInfusion OptionsSterilityNY

Other Leucovorin recalls

All 13
ReportedClassRecallCompanyReasonWhere
DrugCLASS IILeucovorin Calcium for Injection, USP 100 mg/vial single-use vials recalledTeva Pharmaceuticals USASterilityNationwide
DrugCLASS IILeucovorin Calcium for Injection, USP 350 mg/vial single-use vials recalledTeva Pharmaceuticals USASterilityNationwide
DrugCLASS IILeucovorin Calcium for Injection, USP 350 mg/vial single-use vials recalledTeva Pharmaceuticals USASterilityNationwide
DrugCLASS IILeucovorin Calcium for Injection recalled by Teva Pharmaceuticals UTeva Pharmaceuticals USASterilityNationwide
DrugCLASS IILeucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial recalledTeva Pharmaceuticals USASterilityNationwide