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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Cipla Difluprednate Eye Drops Recalled for Sterility Concerns

Agency Publication Date: August 5, 2022
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Summary

Cipla is recalling 7,992 bottles of its Difluprednate Ophthalmic Emulsion 0.05% (difluprednate) eye drops because the bottles may have defective closures that compromise the sterility of the medication. No incidents or injuries have been reported to date, but a loss of sterility in eye medication can lead to serious infections. These prescription eye drops were sold at pharmacies nationwide in the United States.

Risk

Defective bottle seals can allow contaminants to enter the eye drops, making the product no longer sterile. Using non-sterile eye medication poses a moderate risk of developing ocular infections, which could lead to vision loss or other permanent eye damage.

What You Should Do

  1. This recall affects 5 mL bottles of Cipla Difluprednate Ophthalmic Emulsion 0.05% with NDC 69097-341-35. The specific lot affected is DEG3LC2 with an expiration date of 05/2023.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Cipla directly for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Difluprednate Ophthalmic Emulsion 0.05% (5 mL)by Cipla
Variants: 0.05% Strength, 5 mL Bottle, Sterile
Lot Numbers:
DEG3LC2 (Exp 05/2023)
NDC:
69097-341-35

Manufactured by Cipla Ltd., India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90702
Status: Resolved
Manufacturer: CIPLA
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 7,992 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.