Cequa — Class III drug recall D-1172-2023
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2023-09-27, distributed nationwide. Subpotent: Out of Specification result observed for low assay
| Recall number | D-1172-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2023-09-07 |
| Classified | 2023-09-20 |
| Reported by FDA | 2023-09-27 |
| Terminated | 2024-02-13 |
| Distributed | Nationwide (US) |
| Quantity | 69,707 cartons |
| Reason classes | potency, specification failure |
| NDC | 47335-0506, 47335-0506-96, 47335-0507, 47335-0507-97 |
| Lot numbers | 10026, 10027 |
| Expiration dates | 2023-09 |
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
Reason for recall
Subpotent: Out of Specification result observed for low assay
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1172-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.