Ciprofloxacin Ophthalmic Eye Drops Recalled Due to Defective Container
FDC Limited is recalling 136,181 bottles of Ciprofloxacin Ophthalmic Solution due to defective packaging where the cap spike is lodged in the bottle nozzle, preventing product dispensing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a prescription antibiotic eye drop with a defective container that prevents product dispensing. No illnesses or injuries have been reported, but the defect creates a risk-of-harm situation where patients cannot access their prescribed medication.
Plain-English summary
FDC Limited is recalling Ciprofloxacin Ophthalmic Solution USP, 0.3%, distributed by Leading Pharma LLC in Fairfield, NJ. The recall affects approximately 136,181 bottles distributed nationwide. The product is manufactured by FDC Limited in Maharashtra, India.
The affected bottles contain a manufacturing defect in which the spike of the cap becomes lodged in the bottle nozzle, making it impossible to dispense the solution. This defect affects bottles from two lot numbers: Lot 083L111 (expiration 11/30/2025) and Lot 084A032 (expiration 12/31/2025).
Ciprofloxacin ophthalmic solution is a prescription antibiotic eye drop used to treat bacterial eye infections. Patients who have received affected bottles may be unable to access their medication due to the defective packaging.
Consumers who have received affected product should contact their healthcare provider or pharmacy. Do not attempt to force the cap or otherwise manipulate the bottle, as this may compromise the sterile contents. Return the affected bottles to the pharmacy where they were dispensed for replacement.
The recalled product
- Product
- CIPROFLOXACIN (CIPROFLOXACIN)
- Brand
- CIPROFLOXACIN
- Manufacturer
- FDC Limited
- Category
- Drug — Ophthalmic
- Affected units
- 136,181
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot: 083L111
- Exp. 11/30/2025
- 084A032
- Exp. 12/31/2025
UPCs (2)
- 0369315308028
- 0369315308059
Distribution
Distributed nationwide across the United States.
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