Cystaran 0.44% Ophthalmic Solution Recall: Subpotent Drug Risk
Leadiant Biosciences recalls Cystaran 0.44% ophthalmic solution due to subpotent cysteamine hydrochloride. Affected units have specific NDC and lot numbers. Contact for remedy details.
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 active ingredient. This could lead to ineffective treatment for certain eye conditions. The recall affects specific batches with known lot numbers and expiration dates. Read more at govinfonow.com/recall/40813-cystaran-0-44-ophthalmic-solution-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40813-cystaran-0-44-ophthalmic-solution-recall-subpotent-drug-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0550-2018
Cite this page
“Cystaran 0.44% Ophthalmic Solution Recall: Subpotent Drug Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40813-cystaran-0-44-ophthalmic-solution-recall-subpotent-drug-risk. Based on FDA recall #D-0550-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0550-2018%22&limit=1).
Why it’s dangerous
The medication contains less than the required amount of cysteamine hydrochloride, which is the active ingredient. This subpotent level may not provide the intended therapeutic effect for patients using it to treat certain eye conditions.
Who’s affected
Patients prescribed Cystaran 0.44% ophthalmic solution by a doctor. Those with the specific NDC 54482-020-01 and lot number 356075 are most at risk.
How to tell if you have this one
Check for the product name Cystaran 0.44% ophthalmic solution in 15 mL bottles. Look for the NDC code 54482-020-01 and lot number 356075. The expiration date is February 28, 2018.
- Brand
Leadi:ant Biosciences- Category
Drug
What to do — step by step
Check Product Details
Verify the NDC code 54482-020-01 and lot number 356075 on the bottle label.
Where it went and when
Where it was distributed
Distributed in Pennsylvania, and outside the U.S.
FDA distribution: “Product was distributed to one specialty pharmacy distributor in the US Walgreens Specialty Pharmacy 16287, 130 Enterprise Drive Pittsburgh, PA 15275 Foreign Account: 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 9 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-0550-2018 (February 14, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0550-2018 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.