Stop using now Drug recall · FDA · Published August 22, 2022

CIPLA Difluprednate Eye Drops Recall: Risk of Contaminated Drops

CIPLA recalls 0.05% Difluprednate Ophthalmic Emulsion bottles due to potential contamination from broken protective caps. This medication is prescription-only and may cause eye infections if not sterile.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1498-2022Drug CIPLA ›

Stop using this now

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.

Take action

Contact the company

Recalling firmCIPLA10 Independence Blvd · Warren, NJ 07059-2730

✎ GovInfoNow plain-language explainer

CIPLA is recalling prescription eye drops that could become contaminated if the protective cap breaks, exposing the dropper tip to the eye. This risk of infection is serious enough to require immediate action. Read more at govinfonow.com/recall/34360-cipla-difluprednate-eye-drops-recall-risk-of-contaminated-drops.

Source Summary by GovInfoNow · govinfonow.com/recall/34360-cipla-difluprednate-eye-drops-recall-risk-of-contaminated-drops · Updated August 18, 2026 · FDA enforcement record: FDA #D-1498-2022

Cite this page

“CIPLA Difluprednate Eye Drops Recall: Risk of Contaminated Drops.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34360-cipla-difluprednate-eye-drops-recall-risk-of-contaminated-drops. Based on FDA recall #D-1498-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1498-2022%22&limit=1).

The FDA announced on 2022-08-22 that CIPLA is recalling Difluprednate Ophthalmic Emulsion due to a lack of sterility assurance. The hazard stems from defective containers where cap breakage exposes the drop tip. Owners should contact the manufacturer for a remedy.

How to tell if you have it

Brand: CIPLA
Product: Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle
NDC: 76282-708-50
Lot #: DEG5BD2
Expiration Date: Exp 07/2023
Manufacturer for: Exelan Pharmecuticals, Inc., Boca Raton, FL 33432
Units affected: 3,468 bottles

The hazard

The recall addresses a lack of assurance of sterility caused by customer complaints regarding defective containers. Specifically, the breakage of the protective cap exposes the tip of the eye drop, which could compromise sterility.

Context

GovInfoNow's records show CIPLA has 7 other recalls on record since 2020-12-14. Other recent recalls of similar products include Cipla Arformoterol Inhaler Recall (2022-09-29), Cipla Budesonide Inhaler Recall (2022-09-15), and CIPLA Difluprednate Ophthalmic Emulsion 0.05% Recall (2022-08-02). Additional recent recalls include K.C. Pharmaceuticals Sterile Eye Drops AC Recall (2026-03-03), Cipla Lanreotide Injection Recall (2026-03-13), and Cipla Phytonadione Injectable Emulsion Recall (2025-10-31).

How to tell if you have this one

Check for the 5 mL bottle labeled 'Difluprednate Ophthalmic Emulsion, 0.05%'. The specific lot number DEG5BD2 (expiring July 2023) is the recalled batch.

Brand
CIPLA
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide in the USA

Recall number	Product, codes & lots	Quantity	NDC
D-1498-2022	Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.; Lot # DEG5BD2, Exp 07/2023	3,468 bottles	—
D-1499-2022	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.; 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	117,844 bottles	69097-341-35

Based on the official FDA remedy

What to do — step by step

Stop Using Now
Immediately discard the recalled eye drops if you have the lot number DEG5BD2.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

Aug 22, 2022Firm started the recall
Sep 7, 2022FDA classified it Class II
Sep 14, 2022Published in FDA’s Enforcement Report
Nov 27, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have the recalled product?

Discard the product immediately and contact your doctor for a replacement.

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Link to this recall

<a href="https://govinfonow.com/recall/34360-cipla-difluprednate-eye-drops-recall-risk-of-contaminated-drops">CIPLA Difluprednate Eye Drops Recall: Risk of Contaminated Drops (GovInfoNow)</a>

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-1498-2022 (August 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1498-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.