HIGH

Fagron Compounding Services Recalls Ophthalmic Solution Over Incorrect Formulation

Fagron Compounding Services recalled 2,980 syringes of a topical ophthalmic solution on November 20, 2025. The recall stems from an incorrect product formulation that could pose health risks. Consumers should stop using the product immediately and contact their healthcare provider for guidance.

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

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

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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.

The Hazard

The recall is classified as Class II due to an incorrect product formulation. This formulation error poses a high risk to consumers, potentially leading to adverse health effects if administered.

Reported Incidents

There have been no reported injuries or incidents related to the use of this product thus far. Consumers are urged to report any adverse effects to their healthcare provider.

What to Do

Stop using the product immediately. Contact Fagron Compounding Services or your healthcare provider for further guidance. Notifications are being sent out via letter.

Contact Information

For more information, contact Fagron Compounding Services directly. Visit their website or call their customer service for assistance.

Key Facts

  • Recall date: November 20, 2025
  • Quantity recalled: 2,980 syringes
  • NDC: 71266-8240-01
  • Incorrect formulation poses high health risks
  • Consumers advised to stop use immediately

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeTopical Ophthalmic Solution
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot#: C274-000047958
Exp. December 19
2025
Affected States
ALL
Report Date
December 17, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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