Agency classClass IIOur severity:High FDA (Drugs)·D-1328-2022·Announced 2022-08-17

Difluprednate eye drops recalled for defective container closure affecting sterility

Cipla is recalling Difluprednate ophthalmic emulsion nationwide due to defective container closures that compromise sterility assurance. Patients using the affected lot should discontinue use and contact their healthcare provider.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a risk-of-harm product—a sterile ophthalmic medication with defective container closure compromising sterility assurance. No illnesses, injuries, hospitalizations, or deaths have been reported, placing it below Severe but above Moderate due to the inherent risk of infection from unsterile eye medications.

Plain-English summary

Cipla USA, Inc. has issued a nationwide recall of Difluprednate ophthalmic emulsion 0.05% due to defective container closures. The recall affects lot DEG3LC2 (expiration 05/2023), comprising approximately 7,992 bottles distributed throughout the United States.

The defective container closure prevents assurance that the product maintains its required sterility. For ophthalmic medications, sterility is critical to prevent eye infections and other serious complications.

Patients currently using the affected product should discontinue use immediately and contact their prescribing healthcare provider. Healthcare providers treating patients with this medication should verify whether their patients received product from the affected lot and inform them of the recall. The product should not be used.

The recalled product

Product: DIFLUPREDNATE (DIFLUPREDNATE)
Brand: DIFLUPREDNATE
Manufacturer: CIPLA
Category: Drug — Ophthalmic
Hazard: sterility
container-defect
contamination-risk
Affected units: 7,992

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot # DEG3LC2
Exp 05/2023

Distribution

Distributed nationwide across the United States.

Same brand · DIFLUPREDNATE

High
Difluprednate Eye Drops Recalled for Defective Container Sterility Risk
FDA (Drugs) · 2022-09-14
High
FDA Recalls Cipla Difluprednate Eye Drops for Defective Container Caps
FDA (Drugs) · 2022-07-27

Same manufacturer · CIPLA

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Same hazard · sterility