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Stop using now Drug recall · FDA · Published October 18, 2023

Exela ELCYS injection vials recalled for silicone particles in IV fluids

Exela Pharma Sciences recalls 10x10mL ELCYS vials due to silicone particles that could cause blockages or reactions when injected. Affected lots manufactured in 2023.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0118-2024DrugExela ›
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Contact the company

Recalling firmExela Pharma Sciences LLC1245 Blowing Rock Blvd · Lenoir, NC 28645-3618
✎ GovInfoNow plain-language explainer

Exela Pharma Sciences is recalling 10x10mL ELCYS injection vials because they contain silicone particles that could cause blockages or reactions when used for IV infusions. This is a serious safety issue for patients receiving the medication. Read more at govinfonow.com/recall/33052-exela-elcys-injection-vials-recalled-for-silicone-particles-in-iv.

Source Summary by GovInfoNow · govinfonow.com/recall/33052-exela-elcys-injection-vials-recalled-for-silicone-particles-in-iv · Updated August 17, 2026 · FDA enforcement record: FDA #D-0118-2024

Cite this page

“Exela ELCYS injection vials recalled for silicone particles in IV fluids.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33052-exela-elcys-injection-vials-recalled-for-silicone-particles-in-iv. Based on FDA recall #D-0118-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0118-2024%22&limit=1).

Exela Pharma Sciences LLC voluntarily recalled ELCYS (cysteine hydrochloride injection), USP, due to the presence of silicone particulate matter, the FDA said on Oct. 18, 2023. The Class I recall affects 38,200 vials distributed nationwide.

How to tell if you have it

  • Brand: Exela
  • Product: ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL)
  • Package: 10x10 mL Single Dose Sterile Vials
  • NDC (Vial): 51754-1007-1
  • NDC (Carton): 51754-1007-3
  • Lot #: 10000798
  • Expiration Date: 03/31/2025

The hazard

The recall cites the presence of particulate matter, specifically silicone, in the injection vials. The FDA classified this as a Class I hazard.

Context

GovInfoNow's records show Exela Pharma Sciences LLC has seven other recalls on record since April 20, 2018. Recent similar product recalls include GE Healthcare Omnipaque Injection and Omnipaque 300 mg/mL Injection (March 24, 2026) and American Regent Multrys IV injection (July 24, 2026), all citing particulate matter hazards.

How to tell if you have this one

Check for vials labeled 'ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL)' with lot number 10000798 manufactured in 2023. The vials are for intravenous use only and require a prescription.

  • Brand
    Exela
  • Category
    Drug
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Ongoing
  • Distribution
    Nationwide
Recall numberProduct, codes & lotsQuantityNDC
D-0116-20248.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), c) 20x50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.; a) P0001429, EXP 11/30/2023 b) P0001900, P0001902, EXP 08/31/2024; P0001903, P0001909, P0001945, EXP 09/30/2024; P0002002, EXP 11/30/2024; P0002052, EXP 12/31/2024 c) P0001912, EXP 08/31/2024355,220 vials51754-5001-5, 51754-5001-4, 51754-5011-4, 51754-5002-5, 51754-5012-4, 51754-5001-1, 72572-740-01, 72572-740-20
D-0117-2024Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial NDC 51754-2131-1; Carton NDC 51754-2131-4).; Lot # 10001088 exp 07/31/202423,425 vials—
D-0118-2024ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial: NDC 51754-1007-1; Carton: 51754-1007-3).; Lot # 10000798, Expiration Date 03/31/202538,200 vials51754-1007-1, 51754-1007-3
Based on the official FDA remedy

What to do — step by step

  1. Stop using it now

    Immediately stop using any ELCYS vials with lot number 10000798 as they contain silicone particles that could cause serious harm.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 42 days after the firm started it.

1. Firm started the recall: Oct 18, 202312. FDA classified it Class I: Nov 22, 202323. Published in FDA’s Enforcement Report: Nov 29, 202332023
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0118-2024 (October 18, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0118-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA