Cequa Eye Solution (Sun Pharmaceutical) – Potency Issue (2021)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
SUN PHARMACEUTICAL INDUSTRIES INC
Lot Codes / Batch Numbers
Lot # 10009, exp. date 03/2022 10006, exp. date 01/2022
Products Sold
Lot # 10009, exp. date 03/2022 10006, exp. date 01/2022
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials due to Subpotent and Presence of Particulates .. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Subpotent and Presence of Particulates .
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026