CLASS II Drug recall · Reported 14 Sep 2022 · FDA Enforcement Report

Difluprednate Ophthalmic Emulsion recalled by CIPLA

Cipla is recalling Difluprednate Ophthalmic Emulsion, 0.05%, distributed nationwide in the US. The recall was initiated on 22 Aug 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: DEG1HC2, DEG2HC2, DEG3HC2, DEG4HC2, DEG5HC2, DEG6HC2, Exp 01/2023; DEG1IC2, DEG2IC2, DEG3IC2, DEG4IC2, Exp 02/2023; DEG1LC2, DEG2LC2, Exp 05/2023; DEG1BD2, DEG2BD2, DEG3BD2, Exp 07/2023

NDC69097-341

Quantity recalled117,844 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1499-2022
FDA event ID: 90796
Recalling firm: Cipla, Warren, NJ
Brand: Difluprednate
Manufacturer: Cipla USA Inc.
Classification: Class II
Status: Terminated
Recall initiated: 22 Aug 2022
FDA classified: 7 Sep 2022
Reported: 14 Sep 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Eye Drops

Timeline

22 Aug 2022	Recall initiated by company
7 Sep 2022	Classified by FDA	+16 days
14 Sep 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

Which lots are affected?

Lot #: DEG1HC2, DEG2HC2, DEG3HC2, DEG4HC2, DEG5HC2, DEG6HC2, Exp 01/2023; DEG1IC2, DEG2IC2, DEG3IC2, DEG4IC2, Exp 02/2023; DEG1LC2, DEG2LC2, Exp 05/2023; DEG1BD2, DEG2BD2, DEG3BD2, Exp 07/2023

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 90796

This product is part of a recall event; the main page for the event is Difluprednate Ophthalmic Emulsion recalled by CIPLA.

Reported	Class	Recall	Company	Reason	Where
14 Sep 2022	CLASS II	Difluprednate Ophthalmic Emulsion recalled by CIPLA	Cipla	Sterility	Nationwide

More recalls from Cipla

All 14

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Drug	CLASS II	Phytonadione Injectable Emulsion, USP 10mg/mL recalled by CiplaPhytonadione	Cipla	Potency & Assay	Nationwide
12 Oct 2022Drug	CLASS II	Arformoterol Tartrate Inhalation Solution, 15 mcg/ Sterile Unit-Dose recalledArformoterol Tartrate	Cipla	Sterility	Nationwide
5 Oct 2022Drug	CLASS II	Budesonide Inhalation Suspension 0.25mg/, For Inhalation Only recalledBudesonide	Cipla	Sterility	Nationwide
14 Sep 2022Drug	CLASS II	Difluprednate Ophthalmic Emulsion recalled by CIPLA	Cipla	Sterility	Nationwide
17 Aug 2022Drug	CLASS II	Difluprednate Ophthalmic Emulsion recalled by CIPLADifluprednate	Cipla	Sterility	Nationwide

Other Difluprednate recalls

All 4

Reported	Class	Recall	Company	Reason	Where
14 Sep 2022Drug	CLASS II	Difluprednate Ophthalmic Emulsion recalled by CIPLA	Cipla	Sterility	Nationwide
17 Aug 2022Drug	CLASS II	Difluprednate Ophthalmic Emulsion recalled by CIPLADifluprednate	Cipla	Sterility	Nationwide
27 Jul 2022Drug	CLASS II	Difluprednate Ophthalmic Emulsion recalled by CIPLADifluprednate	Cipla	Sterility	Nationwide