Ciprofloxacin Ophthalmic Solution Recalled Due to Defective Container
FDC Limited is recalling 66,528 bottles of Ciprofloxacin ophthalmic solution USP 0.3% due to a manufacturing defect in the container cap that prevents access to the medication. All affected bottles were distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a manufacturing defect that affects product accessibility. No illnesses or injuries are reported in the source material, and the hazard is a container design issue rather than chemical or biological contamination.
Plain-English summary
FDC Limited is recalling Ciprofloxacin ophthalmic solution USP 0.3%, a prescription eye drop medication distributed by Leading Pharma LLC. The recall affects approximately 66,528 bottles distributed nationwide in the United States. Two package sizes are involved: 10 mL bottles (NDC 69315-308-10, Lot 084C040, expiring 02/28/2026) and 2.5 mL bottles (NDC 69315-308-02, Lot 084A024, expiring 12/31/2025).
The bottles are being recalled due to a manufacturing defect in the container. The spike of the cap may become lodged in the nozzle of the bottle, preventing users from dispensing and accessing the medication.
Patients currently using or prescribed this medication should check their bottle against the affected lot numbers and expiration dates listed above. If you have an affected bottle, contact your pharmacy or healthcare provider for a replacement.
The recalled product
- Product
- CIPROFLOXACIN (CIPROFLOXACIN)
- Brand
- CIPROFLOXACIN
- Manufacturer
- FDC Limited
- Category
- Drug — Ophthalmic Solution
- Hazard
- defective-container
- access-obstruction
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#: a) 084C040
- Exp 02/28/2026
- b) 084A024
- Exp12/31/2025.
UPCs (2)
- 0369315308028
- 0369315308059
Distribution
Distributed nationwide across the United States.
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