Difluprednate Ophthalmic Emulsion (CIPLA) – Sterility Concerns (2022)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
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
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
Brand
CIPLA
Lot Codes / Batch Numbers
Lot # DEG3LC2, Exp 05/2023
Products Sold
Lot # DEG3LC2, Exp 05/2023
CIPLA is recalling Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufacture due to Lack of Assurance of Sterility: Complaints received of defective container closure.. 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
Lack of Assurance of Sterility: Complaints received of defective container closure.
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