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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Direct Rx Ciprofloxacin Eye Drops Recalled for Defective Bottle Nozzle

Agency Publication Date: April 15, 2025
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Summary

Direct Rx is recalling 477 bottles of Ciprofloxacin Ophthalmic Solution, 0.3% (5mL), which is a generic version of Ciloxan. The recall was issued because the spike from the cap can become stuck inside the bottle's nozzle, making it impossible to dispense the medication. These products were distributed to physicians and medical facilities in Alabama, California, Florida, Georgia, and Idaho. If you have this medication, you may be unable to receive your prescribed treatment for an eye infection.

Risk

The defective container prevents the solution from being released, which can lead to a delay in treatment for bacterial eye infections. Missing doses of an antibiotic can cause the infection to persist, worsen, or become more difficult to treat.

What You Should Do

  1. The recalled product is Ciprofloxacin Ophthalmic Solution, 0.3% in a 5mL bottle (NDC 61919-795-05) packaged and distributed by Direct Rx.
  2. Identify if your product is affected by checking for lot numbers 11SE2402 (Exp 11/30/2025), 14NO2406 (Exp 12/31/2025), 29OC2420 (Exp 11/30/2025), or 30SE2412 (Exp 11/30/2025).
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Direct Rx for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: CIPROFLOXACIN OPHTH SOLUTION, 0.3% (5mL bottle)
Variants: Generic for CILOXAN, 0.3% Strength
Lot Numbers:
11SE2402 (Exp 11/30/2025)
14NO2406 (Exp 12/31/2025)
29OC2420 (Exp 11/30/2025)
30SE2412 (Exp 11/30/2025)
NDC:
61919-795-05

Recall #: D-0364-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96573
Status: Active
Manufacturer: Direct Rx
Sold By: Physicians; Medical facilities
Manufactured In: United States
Units Affected: 477 bottles.
Distributed To: Alabama, California, Florida, Georgia, Idaho

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.