Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Is Cysteamine recalled?
Not under an active recall.
Cysteamine was recalled 3 times in the past — all now closed. Most recent: Sep 24, 2020.
Most common reason: Wrong potency / content (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cysteamine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Cysteamine recalls on record
none so far in 2026; 3 on record, newest first
Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
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