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 D

Lack of Assurance of Sterility

Recall #: D-1789-2019
Affected scope: N/A
Initiated: June 12, 2019

Compiled from official public sources by the publisher. · Updated September 2026

Infusion Options, Inc. recalled LEUCOVORIN 560 MG / 250 ML NS IVPB; LEUCOVORIN 830 MG / 250 ml NS IVPB; LEUCOVORIN 300 MG… - a moderate-severity action.

LEUCOVORIN 560 MG / 250 ML NS IVPB; LEUCOVORIN 830 MG / 250 ml NS IVPB; LEUCOVORIN 300 MG… was recalled by Infusion Options, Inc. in August 21, 2019. Reason: Lack of Assurance of Sterility. Check the official notice for the remedy. Verify recall #D-1789-2019 with the FDA Drug before acting.

The recall

Infusion Options, Inc. issued this moderate-severity FDA Drug recall-Lack of Assurance of Sterility.

Moderate
severity level: Class II
classification: August 21, 2019
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1789-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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

Reason for recall

Lack of Assurance of Sterility

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	D-1789-2019
Date reported	August 21, 2019
Date initiated	June 12, 2019
Recalling firm	Infusion Options, Inc.
Firm location	Brooklyn, NY
Affected scope	N/A
Distribution	NY only

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-1789-2019) and product description against the item you own. Search the archive
Confirm the current status with FDA Drug before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Lack of Assurance of Sterility

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on August 21, 2019. Severity: Moderate. Recall number: D-1789-2019.

Where was the recalled product distributed? ▼

Distribution: NY only.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

Lisinopril and Hydrochlorothiazide Tablet… 2019-08-21 Nitrofurantoin Monohydrate/Macrycrystals … 2019-08-21 Macrobid Urinary Tract Anitbacterial, 100… 2019-08-21 CVS Health Glycerin Suppositories, 50-cou… 2019-08-21

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

VOLUMAT MC AGILIA US, Infusion Pump, REF … 2019-08-21 Vigilant Agilia, Vigilant Drug'Lib, REF Z… 2019-08-21 Medline Primary Warmer Pack, Product No. … 2019-08-21 Centurion Convenience Kits, containing BD… 2019-08-21

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Drug, reported August 21, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026