CLASS III Drug recall · Reported 26 May 2021 · FDA Enforcement Report
Cequa (cyclosporine ophthalmic solution) 09%-Use Vials recalled
Sun Pharmaceutical Industries is recalling Cequa (cyclosporine ophthalmic solution) 09%-Use Vials (6 pouches x-use vials each)), distributed nationwide in the US. The recall was initiated on 7 May 2021 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-0391-2021
- FDA event ID
- 87922
- Recalling firm
- Sun Pharmaceutical Industries, Princeton, NJ
- Brand
- Cequa
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 May 2021
- FDA classified
- 20 May 2021
- Reported
- 26 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Eye Drops
Timeline
| 7 May 2021 | Recall initiated by company | |
| 20 May 2021 | Classified by FDA | +13 days |
| 26 May 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent and Presence of Particulates .
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 Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96
Where it was distributed
Nationwide in the US
Questions about this recall
Is Cequa (cyclosporine ophthalmic solution) 09%-Use Vials (6 pouches x-use vials each)) recalled?
Yes. Sun Pharmaceutical Industries recalled Cequa (cyclosporine ophthalmic solution) 09%-Use Vials (6 pouches x-use vials each)) on 7 May 2021. The recall is Class III and its status is Terminated. Recall number D-0391-2021.
Why was it recalled?
Subpotent and Presence of Particulates .
Which lots are affected?
Lot # 10009, exp. date 03/2022 10006, exp. date 01/2022
Where was it sold?
Nationwide in the US
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 21 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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Other Cyclosporine recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) 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) recalledCequa | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) 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 |