Ciprofloxacin Ophthalmic Solution Recalled for Defective Container Cap
Direct Rx is recalling Ciprofloxacin Ophthalmic Solution 0.3% because the cap spike may lodge in the bottle nozzle, preventing the medication from being dispensed.
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 a defective container that prevents proper product dispensing. No illnesses or injuries have been reported; the hazard is a packaging defect that impairs product functionality.
Plain-English summary
Direct Rx is recalling Ciprofloxacin Ophthalmic Solution 0.3% 5mL bottles (generic for CILOXAN, NDC 61919-795-05) due to a defective container. The spike of the cap can become lodged in the nozzle of the bottle, which prevents the solution from being dispensed.
The recall affects 477 bottles distributed to physicians and medical facilities in Alabama, California, Florida, Georgia, and Idaho. The affected lots are: Lot 11SE2402 (Exp 11/30/2025), Lot 14NO2406 (Exp 12/31/2025), Lot 29OC2420 (Exp 11/30/2025), and Lot 30SE2412 (Exp 11/30/2025).
Patients and healthcare providers should stop using the affected bottles immediately. If you have received this product, contact your pharmacy or healthcare provider for a replacement.
The recalled product
- Product
- CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
- Manufacturer
- Direct Rx
- Category
- Drug — Ophthalmic Solution
- Affected units
- 477
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 (5)
- Lot 11SE2402
- Exp Date: 11/30/2025 Lot 14NO2406
- Exp Date: 12/31/2025 Lot 29OC2420
- Exp Date: 11/30/2025 Lot 30SE2412
- Exp Date: 11/30/2025
Distribution
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