Ciprofloxacin Solution
FDA Recall NDC 69315-308
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Ciprofloxacin (NDC 69315-308). A significant event, classified as Class II, was initiated on Mar 11, 2025 by Leading Pharma, Llc. The reported reason for this action was: "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"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
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
Mar 11, 2025
Mar 26, 2025
90960 bottles
Recall Profile & Regulatory Data
Event ID
96495
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
FDC Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S
Product Description
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05
Batch or Lot Expiration Information
Lot# Lot: 084A067, Exp 12/31/2025
Affected Packages Involved in this Recall
69315-308-02Product
69315-308-05Product
69315-308-10Product
Class II Ongoing
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
Dec 16, 2024
Jan 15, 2025
136,181 bottles
Recall Profile & Regulatory Data
Event ID
96014
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
FDC Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05
Batch or Lot Expiration Information
Lot# Lot: 083L111, Exp. 11/30/2025; 084A032, Exp. 12/31/2025
Affected Packages Involved in this Recall
69315-308-02Product
69315-308-05Product
69315-308-10Product
Class II Ongoing
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.
Jul 23, 2024
Aug 07, 2024
66,528 bottles
Recall Profile & Regulatory Data
Event ID
95027
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
FDC Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. A. Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# : a) 084C040, Exp 02/28/2026; b) 084A024, Exp12/31/2025.
Affected Packages Involved in this Recall
69315-308-02Product
69315-308-05Product
69315-308-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
