Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Cystaran (cysteamine ophthalmic solution) 0.44% Recalled by LEADIANT BIOSCIENCES, INC Due to Subpotent drug: Out of specification for an active...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LEADIANT BIOSCIENCES, INC directly.
Affected Products
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
Quantity: 3,398 bottles
Why Was This Recalled?
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Where Was This Sold?
This product was distributed to 1 state: PA
About LEADIANT BIOSCIENCES, INC
LEADIANT BIOSCIENCES, INC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report