Quick Facts at a Glance
- Recall Date
- November 20, 2025
- Hazard Level
- HIGH
- Brand
- Fagron Compounding Services
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Fagron Compounding Services
- Product type
- Topical Ophthalmic Solution
- Model numbers
- Lot#: C274-000047958, Exp. December 19, 2025
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 20, 2025
Reported by FDA DRUG
December 17, 2025
RecallRadar source check
December 24, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Incorrect Product Formulation
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Fagron Compounding Services or your healthcare provider for guidance. Notification method: Letter
About This Product
The product is a topical ophthalmic solution used for eye care, including pupil dilation and inflammation control. Consumers typically buy this for procedures or conditions requiring eye examination or treatment.
Why This Is Dangerous
The product's incorrect formulation could lead to ineffective treatment or adverse reactions in patients. It is crucial to use properly formulated medications for ocular applications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses a high health risk, necessitating immediate cessation of use and consultation with healthcare professionals for any consumers who have used the product.
Practical Guidance
How to identify if yours is affected
- Locate the lot number on the syringe packaging.
- Check if it matches Lot#: C274-000047958.
- Verify the expiration date, which is December 19, 2025.
Where to find product info
You can find serial numbers and lot numbers on the packaging of the syringe, typically near the expiration date.
What timeline to expect
Expect a timeline of approximately 4-6 weeks for processing refunds or replacement.
If the manufacturer is unresponsive
- Follow up with customer service via phone or email.
- Document all communications for your records.
- Contact the FDA if you do not receive a response.
How to prevent similar issues
- Always check the NDC and lot numbers before using any medication.
- Purchase medications from reputable sources to ensure quality and safety.
- Be aware of recalls in the pharmaceutical industry.
Documentation advice
Keep all receipts, correspondence regarding the recall, and any medical advice received.
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Product Details
The affected product is Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, packaged in 0.5mL single-use syringes. It is distributed by Fagron Sterile Services, located at 8710 E 34th St N, Wichita, KS 67226. The National Drug Code (NDC) is 71266-8240-01.
Key Facts
- Recall date: November 20, 2025
- Quantity recalled: 2,980 syringes
- Incorrect formulation poses high health risks
- Consumers advised to stop use immediately
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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