CLASS III Drug recall · Reported 13 Apr 2022 · FDA Enforcement Report
Cequa (cyclosporine ophthalmic solution) recalled
SUN Pharmaceutical Industries is recalling Cequa (cyclosporine ophthalmic solution) 0.09%, distributed nationwide in the US. The recall was initiated on 1 Apr 2022 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0770-2022
- FDA event ID
- 89917
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Brand
- Cequa
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Apr 2022
- FDA classified
- 14 Apr 2022
- Reported
- 13 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Eye Drops
Timeline
| 1 Apr 2022 | Recall initiated by company | |
| 13 Apr 2022 | Published in enforcement report | +12 days |
| 14 Apr 2022 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Product as listed by the FDA
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 was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Which lots are affected?
Lot: 10014, 10016, Exp 08/2022
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
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Other Cyclosporine recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) 0.09%-Use Vials recalledCequa | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Neoral soft gelatin capsules (cyclosporine capsules recalledNeoral | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) 0.09%-Use Vials recalledCequa | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) 0.09%-Use Vials recalledCequa | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Cyclosporine USP, for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |