Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ciprofloxacin ophthalmic solution USP Recalled by FDC Limited Due to Defective container: unable to get the solution out...
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 FDC Limited directly.
Affected Products
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India.
Quantity: 66,528 bottles
Why Was This Recalled?
Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About FDC Limited
FDC Limited 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