Class III · Low risk
Klarity-C Drops
Subpotent Drug
Is Cyclosporine recalled?
Yes — there is an active recall. 4 ongoing FDA recalls mention Cyclosporine (27 total). Check the affected lots below.
Most common reason: Sterility / contamination (13 of these recalls)
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
Klarity-C (cyclosporine)
Lack of Assurance of Sterility
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent: Out of Specification result observed for low assay
Class II · Moderate risk
Cyclosporine
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Neoral soft gelatin capsules
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Class II · Moderate risk
Cyclosporine 2% Mct Oil Susp
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent and Presence of Particulates .
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent
Class II · Moderate risk
Cyclosporine 1% Human Eye Drops
Lack of Process Controls
Class II · Moderate risk
Cyclosporine USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
CycloSPORINE Capsules
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
Class II · Moderate risk
CycloSPORINE Capsules
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Class II · Moderate risk
Cyclosporine 1% Opth Sol
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclosporine A active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Cyclosporine 0.045 % Sol PF
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Cyclosporine/corn oil stock vehicle oil packaged in an amber glass injectable vial
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
Cyclosporine suspending vehicle packaged in an amber glass injectable vial
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
Cyclosporine 200 mg/mL opthalmic suspension packaged in an amber glass injectable vial
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
Cyclosporine Drops
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Cyclosporine Injection
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
Cyclosporine Ophthalmic
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Cyclosporine 2% ophthalmic
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
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