Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Difluprednate Ophthalmic Emulsion 0.05% Recalled by CIPLA Due to Lack of Assurance of Sterility: Complaints received of...
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%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
Quantity: 7,992 bottles
Why Was This Recalled?
Lack of Assurance of Sterility: Complaints received of defective container closure.
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