Cyclosporine recalls: 7 FDA reports
Recalls involving Cyclosporine. What was wrong with each batch, and how the FDA graded the risk.
7Reports
0Class I
0Ongoing
2023-09-27Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL
D-1172-2023 · Class III · reported 2023-09-27 · Terminated
- Why it was recalled
- Subpotent: Out of Specification result observed for low assay
- Product
- Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96
- Where it went
- Nationwide wide in the USA
- How much
- 69,707 cartons
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules p
D-1543-2022 · Class II · reported 2022-10-05 · Terminated
- Why it was recalled
- CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
- Product
- Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
- Where it went
- Nationwide and Puerto Rico
- How much
- 132,999 cartons
Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per
D-0770-2022 · Class III · reported 2022-04-13 · Terminated
- Why it was recalled
- Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
- Product
- Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-50211 Coutances Cedex, France, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-506-96
- Where it went
- Nationwide in the USA.
- How much
- 73,030 boxes
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL
D-0391-2021 · Class III · reported 2021-05-26 · Terminated
- Why it was recalled
- Subpotent and Presence of Particulates .
- Product
- Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96
- Where it went
- Nationwide in the US
- How much
- N/A
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL
D-0289-2021 · Class III · reported 2021-03-10 · Terminated
- Why it was recalled
- Subpotent
- Product
- Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96
- Where it went
- Nationwide and Australia
- How much
- 37,400 cartons/60 vials per carton
CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Pa
D-0490-2017 · Class II · reported 2017-03-08 · Terminated
- Why it was recalled
- Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
- Product
- CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25
- Where it went
- Nationwide
- How much
- 454 cartons
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario,
D-0475-2017 · Class II · reported 2017-03-01 · Terminated
- Why it was recalled
- Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
- Product
- CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0
- Where it went
- Distributed Nationwide
- How much
- 19,584 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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