Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Difluprednate Ophthalmic Emulsion Recalled by CIPLA Due to Lack of Assurance of Sterility: customer complaint for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CIPLA directly.
Affected Products
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.
Quantity: 117,844 bottles
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CIPLA
CIPLA has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report