Quick answers
- What is Cystaran?
- Cystaran is a brand name of Cysteamine hydrochloride, a prescription medicine. The FDA NDC Directory lists 2 Cystaran products in 1 strength and form.
- Who makes Cystaran?
- Leadiant Biosci Inc holds the FDA application for Cystaran (NDA200740, approved October 2, 2012).
- Is there a generic or store brand of Cystaran?
- Other products of Cysteamine hydrochloride are listed with the FDA, but none in exactly the same strength and form as a Cystaran product.
- Has Cystaran been recalled?
- FDA enforcement reports list 3 recalls of Cystaran products; the newest started September 24, 2020. A recall usually concerns specific lots, not every product.
What Cystaran is
Each Cystaran product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Cysteamine hydrochloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| cysteamine hydrochloride 6.5 mg/mL solution (ophthalmic) | Cystaran | None listed | — |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Cysteamine hydrochloride →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA200740 | Leadiant Biosci Inc | October 2, 2012 | 2 |
Companies that list Cystaran
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Cystaran products.
- Leadiant Biosciences, Inc.2 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: 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
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.