Quick answers
- What is Cysteine hydrochloride used for?
- The FDA-approved label (Elcys, Exela Pharma Sciences, LLC, April 9, 2026) says: “ELCYS ® is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN); and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN. It can also be added to amino acid solutions to provide a more complete profile of amino acids for protein synthesis. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cysteine hydrochloride have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cysteine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cysteine hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started October 18, 2023 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Cysteine hydrochloride?
- 2 companies list prescription products of Cysteine hydrochloride in the FDA NDC Directory, including Exela Pharma Sciences, LLC and Baxter Healthcare Corporation.
What Cysteine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ELCYS ® is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN); and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN. It can also be added to amino acid solutions to provide a more complete profile of amino acids for protein synthesis. …
— FDA label: Elcys, Exela Pharma Sciences, LLC, effective April 9, 2026. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Elcys |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Exela Pharma Sciences, LLC2 products
- Baxter Healthcare Corporation1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 18, 2023 · Class I · Ongoing · D-0118-2024
Presence of Particulate Matter: Silicone
ELCYS (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 28 — Exela Pharma Sciences LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1486165, 1667993, 2169281, 2671585 |
|---|---|
| SPL set ID of the quoted label | 52317b38-b2e6-4a1c-b5b0-43cada0d205e |
| FDA labels (SPL) | 3 |
| FDA applications | NDA210660, NDA212535 |
| Active ingredients (FDA) | CYSTEINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Elcys, Exela Pharma Sciences, LLC, effective April 9, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →