CLASS II Drug recall · Reported 27 Jul 2022 · FDA Enforcement Report
Difluprednate Ophthalmic Emulsion recalled by CIPLA
CIPLA is recalling Difluprednate Ophthalmic Emulsion, 05%, distributed nationwide in the US. The recall was initiated on 14 Jul 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-1283-2022
- FDA event ID
- 90608
- Recalling firm
- CIPLA, Warren, NJ
- Brand
- Difluprednate
- Manufacturer
- Cipla USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jul 2022
- FDA classified
- 20 Jul 2022
- Reported
- 27 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 14 Jul 2022 | Recall initiated by company | |
| 20 Jul 2022 | Classified by FDA | +6 days |
| 27 Jul 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%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34, Verna Industrial area, Verna - Goa, 403722, India; Mfd. for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-341-35.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Difluprednate Ophthalmic Emulsion, 05% recalled?
Yes. CIPLA recalled Difluprednate Ophthalmic Emulsion, 05% on 14 Jul 2022. The recall is Class II and its status is Terminated. Recall number D-1283-2022.
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?
Batch# DEG4LC2, exp. date 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 21 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 recalled by CIPLAArformoterol Tartrate | CIPLA | Sterility | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension 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 3| 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 CIPLADifluprednate | CIPLA | Sterility | Nationwide |