Class II · Moderate risk
Cyclosporine 1% ophthalmic drops
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Is Cyclosporine recalled?
Yes — there is an active recall. 4 ongoing FDA recalls mention Cyclosporine (27 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cyclosporine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Cyclosporine recalls on record
none so far in 2026; 27 on record, newest first
Class II · Moderate risk
Cyclosporine
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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