CIPLA recalls Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd.,
CIPLA recalls 5mL Difluprednate Ophthalmic Emulsion 0.05% bottles due to container closure defects that may compromise sterility. Affected lots manufactured in India for Cipla USA.
Lower-risk recall
Lack of Assurance of Sterility: Complaints received of defective container closure.
Contact the company & request your remedy
What happened, in plain English
CIPLA is recalling 5mL Difluprednate Ophthalmic Emulsion 0.05% bottles because the container closure may not be sterile. This could lead to infections if the medication is used improperly. The recall affects specific lots manufactured in India for Cipla USA. Read more at govinfonow.com/recall/34383-cipla-difluprednate-ophthalmic-emulsion-0-05-recall-container-closure-defect.
Source Summary by GovInfoNow · govinfonow.com/recall/34383-cipla-difluprednate-ophthalmic-emulsion-0-05-recall-container-closure-defect · Updated September 23, 2026 · FDA enforcement record: FDA #D-1328-2022
Cite this page
“CIPLA Difluprednate Ophthalmic Emulsion 0.05% Recall: Container Closure Defect.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/34383-cipla-difluprednate-ophthalmic-emulsion-0-05-recall-container-closure-defect. Based on FDA recall #D-1328-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1328-2022%22&limit=1).
Why it’s dangerous
The container closure may not be sterile, which could lead to infections if the medication is used improperly. This defect was reported through complaints about the product's sterility.
Who’s affected
People who have the specific 5mL Difluprednate Ophthalmic Emulsion 0.05% bottles manufactured by Cipla Ltd. in India for Cipla USA. Those with eye conditions requiring this medication are most at risk.
How to tell if you have this one
Check for the 5mL bottle labeled Difluprednate Ophthalmic Emulsion 0.05% with lot number DEG3LC2, manufactured in India for Cipla USA. The expiration date is May 2023.
- Brand
CIPLA- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number DEG3LC2 on the bottle label to confirm if it's affected.
Questions people ask
Is this product safe to use?
The product may not be sterile due to container closure defects, so it should not be used until the recall is addressed.
How can I tell if I have the recalled product?
Check for the 5mL bottle labeled Difluprednate Ophthalmic Emulsion 0.05% with lot number DEG3LC2, manufactured in India for Cipla USA.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact CIPLA for guidance on safe disposal or alternatives.
Contact CIPLA
We’ve drafted a message you can send CIPLA to request your refund or repair — edit it as you like.
Subject: Recall D-1328-2022 — CIPLA CIPLA Hello, I own a CIPLA that is covered by recall D-1328-2022 from CIPLA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1328-2022 (August 2, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1328-2022 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.