Leadiant Cystaran 0.44% Ophthalmic Solution Recall: Subpotent Drug Risk
Leadiant Biosciences recalls Cystaran 0.44% ophthalmic solution due to subpotent cysteamine hydrochloride. Affected lots expire June 2018 or July 2018. Do not use if you have this product.
Lower-risk recall
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Contact the company
What happened, in plain English
Leadiant Biosciences is recalling Cystaran 0.44% ophthalmic solution because it contains less than the required amount of cysteamine hydrochloride. This could lead to ineffective treatment for certain eye conditions. The product is prescription-only and sold with specific lot numbers. Read more at govinfonow.com/recall/40626-leadiant-cystaran-0-44-ophthalmic-solution-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40626-leadiant-cystaran-0-44-ophthalmic-solution-recall-subpotent-drug-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0683-2018
Cite this page
“Leadiant Cystaran 0.44% Ophthalmic Solution Recall: Subpotent Drug Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40626-leadiant-cystaran-0-44-ophthalmic-solution-recall-subpotent-drug-risk. Based on FDA recall #D-0683-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0683-2018%22&limit=1).
Why it’s dangerous
The product contains less than the specified amount of cysteamine hydrochloride, an active ingredient. This subpotency means the medication may not work effectively for treating certain eye conditions. The issue is related to manufacturing quality control.
Who’s affected
Prescription patients using Cystaran 0.44% ophthalmic solution with lot numbers 35866 (expiring June 2018) or 358663 (expiring July 2018). Patients with specific eye conditions requiring this medication are most at risk.
How to tell if you have this one
Check the product label for the lot number: 35866 (expires June 2018) or 358663 (expires July 2018). The product is a prescription-only 15 mL bottle of Cystaran 0.44% ophthalmic solution.
- Brand
Leadiant Biosciences- Category
Drug
What to do — step by step
Check Product Label
Look for lot numbers 35866 (expiring June 2018) or 358663 (expiring July 2018) on the bottle.
Where it went and when
Where it was distributed
Distributed in Pennsylvania, and outside the U.S.
FDA distribution: “Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Pennsylvania.
Recall timeline
FDA terminated this recall 8 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-0683-2018 (April 9, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0683-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.