CLASS III Drug recall · Reported 27 Sep 2023 · FDA Enforcement Report
Cequa (cyclosporine ophthalmic solution) 0.09%-Use Vials recalled
SUN Pharmaceutical Industries is recalling Cequa (cyclosporine ophthalmic solution) 0.09%-Use Vials (6 pouches x-use vials each)), distributed nationwide in the US. The recall was initiated on 7 Sep 2023 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-1172-2023
- FDA event ID
- 93006
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Brand
- Cequa
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Sep 2023
- FDA classified
- 20 Sep 2023
- Reported
- 27 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 7 Sep 2023 | Recall initiated by company | |
| 20 Sep 2023 | Classified by FDA | +13 days |
| 27 Sep 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent: Out of Specification result observed for low assay
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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 was distributed
Nationwide wide in the USA
Questions about this recall
Why was it recalled?
Subpotent: Out of Specification result observed for low assay
Which lots are affected?
Lot# 10026, Lot 10027, Exp. 09/2023.
Where was it sold?
Nationwide wide 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.
More recalls from SUN Pharmaceutical Industries
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|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
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Other Cyclosporine recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Neoral soft gelatin capsules (cyclosporine capsules recalledNeoral | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) recalledCequa | SUN Pharmaceutical Industries | Particulate Matter | 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 |