Recall archive / FDA drug enforcement

Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., ... — FDA record D-1328-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 2, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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.
Reason: Lack of Assurance of Sterility: Complaints received of defective container closure.
Classification: Class II
Recalling firm: CIPLA
Quantity: 7,992 bottles
Agency-reported status: Terminated
Source record identifier: D-1328-2022

Open the official record

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Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot # DEG3LC2, Exp 05/2023

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide in the USA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Aug 17, 2022
Recall initiation date: Aug 2, 2022
Center classification date: Aug 5, 2022
Termination date: Nov 27, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.