CLASS II Drug recall · Reported 17 Aug 2022 · FDA Enforcement Report
Difluprednate Ophthalmic Emulsion recalled by CIPLA
Cipla is recalling Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, distributed nationwide in the US. The recall was initiated on 2 Aug 2022 and the FDA has classified it as Class II.
Check your package
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-1328-2022
- FDA event ID
- 90702
- Recalling firm
- Cipla, Warren, NJ
- Brand
- Difluprednate
- Manufacturer
- Cipla USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Aug 2022
- FDA classified
- 5 Aug 2022
- Reported
- 17 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 2 Aug 2022 | Recall initiated by company | |
| 5 Aug 2022 | Classified by FDA | +3 days |
| 17 Aug 2022 | Published in enforcement report | +12 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: Complaints received of defective container closure.
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%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Complaints received of defective container closure.
Which lots are affected?
Lot # DEG3LC2, Exp 05/2023
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.
More recalls from Cipla
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phytonadione Injectable Emulsion, USP 10mg/mL recalled by CiplaPhytonadione | Cipla | Potency & Assay | Nationwide |
| Drug | CLASS II | Arformoterol Tartrate Inhalation Solution, 15 mcg/ Sterile Unit-Dose recalledArformoterol Tartrate | Cipla | Sterility | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension 0.25mg/, For Inhalation Only recalledBudesonide | Cipla | Sterility | Nationwide |
| Drug | CLASS II | Difluprednate Ophthalmic Emulsion recalled by CIPLADifluprednate | Cipla | Sterility | Nationwide |
| Drug | CLASS II | Difluprednate Ophthalmic Emulsion recalled by CIPLA | Cipla | Sterility | Nationwide |
Other Difluprednate recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Difluprednate Ophthalmic Emulsion recalled by CIPLADifluprednate | Cipla | Sterility | Nationwide |
| Drug | CLASS II | Difluprednate Ophthalmic Emulsion recalled by CIPLA | Cipla | Sterility | Nationwide |
| Drug | CLASS II | Difluprednate Ophthalmic Emulsion recalled by CIPLADifluprednate | Cipla | Sterility | Nationwide |