Leadiant Cystaran 0.44% Ophthalmic Solution Recall: Subpotent Drug Risk
Leadiant Biosciences recalls Cystaran 0.44% ophthalmic solution due to decreased active ingredient. Patients should contact their doctor for alternative treatment options.
Lower-risk recall
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Contact the company
What happened, in plain English
Leadiant Biosciences is recalling Cystaran 0.44% ophthalmic solution because testing found lower levels of the active ingredient. This could mean the medication isn't as effective as it should be for treating certain eye conditions. Read more at govinfonow.com/recall/36765-leadiant-cystaran-0-44-ophthalmic-solution-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36765-leadiant-cystaran-0-44-ophthalmic-solution-recall-subpotent-drug-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0034-2021
Cite this page
“Leadiant Cystaran 0.44% Ophthalmic Solution Recall: Subpotent Drug Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36765-leadiant-cystaran-0-44-ophthalmic-solution-recall-subpotent-drug-risk. Based on FDA recall #D-0034-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0034-2021%22&limit=1).
Why it’s dangerous
The product contains less than the required amount of cysteamine HCl, the active ingredient. This could lead to reduced effectiveness in treating certain eye conditions. However, the recall does not indicate a risk of serious injury or harm.
Who’s affected
Patients prescribed Cystaran 0.44% ophthalmic solution by a doctor. Those with specific eye conditions requiring this medication are most at risk.
How to tell if you have this one
Check for the 15 mL bottle labeled 'Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, Sterile, Rx Only'. The product was manufactured by Hi-Tech Pharmacal Co Inc. for Leadiant Biosciences, Inc. and has NDC 54482-020-01.
- Brand
Leadiant Biosciences- Category
Drug
What to do — step by step
Contact Your Doctor
Your doctor can provide alternative treatment options for your eye condition.
Where it went and when
Where it was distributed
Distributed in Pennsylvania, and outside the U.S.
FDA distribution: “PA and Italy” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Pennsylvania.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0034-2021 (September 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0034-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.