Exela ELCYS injection vials recalled for silicone particles in IV fluids

Take action

Contact the company & request your remedy

Recalling firmExela Pharma Sciences LLC1245 Blowing Rock Blvd, N/A · Lenoir, NC 28645-3618

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

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.

Why it’s dangerous

Silicone particles in the vials could cause blockages in IV lines or trigger adverse reactions when the medication is injected into the bloodstream. This poses a risk of serious complications during treatment.

Who’s affected

Patients prescribed ELCYS injections by healthcare providers using the recalled vials. Those with the specific lot number 10000798 are most at risk.

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

Based on the official FDA remedy

What to do — step by step

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

✎ GovInfoNow

Questions people ask

Is this product safe to use?

No, the recalled vials contain silicone particles that could cause blockages or reactions when injected, so they should not be used.

What should I do if I have the recalled vials?

Immediately stop using them and contact your healthcare provider for instructions on safe alternatives.

How can I check if my vials are recalled?

Look for the lot number 10000798 on the vial packaging; these vials were manufactured in 2023 and are for intravenous use only.

Take action

Contact Exela

We’ve drafted a message you can send Exela to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0118-2024 — Exela Exela

Hello,

I own a Exela that is covered by recall D-0118-2024 from Exela.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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.

Exela Pharma Sciences LLC recalls ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For

Stop using this now