Ciprofloxacin Ophthalmic Solution Recalled Nationwide for Defective Container Cap
Ciprofloxacin Ophthalmic Solution is being recalled because the cap spike is lodged in the bottle nozzle, preventing patients from accessing the medication. Affected lot 084A067 was 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: FDA Class II recall with no reported illnesses or injuries. The hazard is a mechanical packaging defect (cap spike lodged in bottle nozzle) that prevents product access but poses no direct health risk.
Plain-English summary
FDC Limited, with distribution by Leading Pharma LLC, is recalling Ciprofloxacin Ophthalmic Solution USP 0.3% nationwide. The recall affects Lot 084A067 (expiration 12/31/2025), consisting of approximately 90,960 bottles.
The reason for the recall is a defective container: the spike of the bottle cap becomes lodged in the nozzle, preventing patients from accessing the medication inside.
Patients with affected bottles should stop using the product and contact their pharmacy for a replacement. Since this is an Rx-only medication, consultation with the prescribing healthcare provider is recommended if there are questions about treatment discontinuation or alternatives.
The recalled product
- Product
- CIPROFLOXACIN (CIPROFLOXACIN)
- Brand
- CIPROFLOXACIN
- Manufacturer
- FDC Limited
- Category
- Drug — Ophthalmic Solution
- Hazard
- defective-container
- access-impaired
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 (2)
- Lot: 084A067
- Exp 12/31/2025
UPCs (2)
- 0369315308028
- 0369315308059
Distribution
Distributed nationwide across the United States.
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