CIPLA recalls Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies
Cipla recalls 0.05% Difluprednate Ophthalmic Emulsion bottles due to potential contamination from broken protective caps. This may compromise eye drop sterility. Affected products have specific batch numbers and expiration dates.
Use caution until it’s fixed
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.
Contact the company & request your remedy
What happened, in plain English
Cipla is recalling 5ml eye drop bottles that could have broken protective caps, risking contamination of the eye drops. This is a serious issue because contaminated eye drops could cause infections or other eye problems. Read more at govinfonow.com/recall/34426-cipla-difluprednate-eye-drops-recall-risk-of-contaminated-drops.
Source Summary by GovInfoNow · govinfonow.com/recall/34426-cipla-difluprednate-eye-drops-recall-risk-of-contaminated-drops · Updated September 23, 2026 · FDA enforcement record: FDA #D-1283-2022
Cite this page
“Cipla Difluprednate Eye Drops Recall: Risk of Contaminated Drops.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/34426-cipla-difluprednate-eye-drops-recall-risk-of-contaminated-drops. Based on FDA recall #D-1283-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1283-2022%22&limit=1).
Why it’s dangerous
The protective cap on the eye drop bottle can break, exposing the eye drop tip to the air. This could allow bacteria to enter the bottle, making the eye drops unsafe for use and risking eye infections.
Who’s affected
People with prescriptions for Cipla's Difluprednate Ophthalmic Emulsion 0.05% 5ml bottles. Those who have the specific batch numbers and expiration dates listed in the recall are most at risk.
How to tell if you have this one
Check for the product name 'Difluprednate Ophthalmic Emulsion 0.05% 5ml bottles' with batch number DEG4LC2 and expiration date 05/2023. The product was manufactured by Cipla Ltd. in India and distributed by Cipla USA.
- Brand
Cipla- Category
Drug
What to do — step by step
Check Product Details
Look for the batch number DEG4LC2 and expiration date 05/2023 on the bottle label.
Questions people ask
Is this product safe to use?
The recall states that broken protective caps could expose the eye drop tip, risking contamination. If the cap is broken, do not use the product.
What should I do if I have this product?
Check the batch number and expiration date. If it matches DEG4LC2 with expiration 05/2023, contact Cipla for instructions.
How can I confirm if I have the recalled product?
Look for the batch number DEG4LC2 and expiration date 05/2023 on the bottle label. The product was manufactured by Cipla Ltd. in India and distributed by Cipla USA.
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-1283-2022 — Cipla Cipla Hello, I own a Cipla that is covered by recall D-1283-2022 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-1283-2022 (July 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1283-2022 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.