Quick answers
- What is Cysteamine hydrochloride used for?
- The FDA-approved label (Cystadrops, Recordati Rare Diseases, Inc., June 6, 2025) says: “CYSTADROPS is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis. CYSTADROPS is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cysteamine hydrochloride have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cysteamine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cysteamine hydrochloride been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started September 24, 2020 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Cysteamine hydrochloride?
- 2 companies list prescription products of Cysteamine hydrochloride in the FDA NDC Directory, including Leadiant Biosciences, Inc. and Recordati Rare Diseases, Inc..
What Cysteamine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CYSTADROPS is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis. CYSTADROPS is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.
— FDA label: Cystadrops, Recordati Rare Diseases, Inc., effective June 6, 2025. Read the full label on DailyMed →
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.
Forms and how it is given
| Dosage forms | Solution |
|---|---|
| Route | Ophthalmic |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Cystaran, Cystadrops |
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.
- Leadiant Biosciences, Inc.2 products
- Recordati Rare Diseases, Inc.1 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.
-
September 24, 2020 · Class III · Terminated · D-0034-2021
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharmacal Co Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 2 — Leadiant Biosciences, Inc.
-
April 9, 2018 · Class III · Terminated · D-0683-2018
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amityville, NY 11701 for Leadiant Biosciences, Inc. Gaithersburg, MD 20878, NDC 54482-020-01 — LEADIANT BIOSCIENCES, INC
-
February 14, 2018 · Class III · Terminated · D-0550-2018
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01 — LEADIANT BIOSCIENCES, INC
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
| SPL set ID of the quoted label | 5d2bcce3-9b89-4141-aeb7-db00449047f5 |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | NDA200740, NDA211302 |
| Active ingredients (FDA) | CYSTEAMINE HYDROCHLORIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cystadrops, Recordati Rare Diseases, Inc., effective June 6, 2025; 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 →