Fagron Recalls Compounded Ophthalmic Syringes Over Incorrect Formulation
Key Takeaways
- Fagron Sterile Services has issued a voluntary Class II recall of a compounded ophthalmic combination product due to incorrect product formulation.
- The recall affects 2980 single-use syringes of tropicamide/cyclopentolate/phenylephrine/ketorolac ophthalmic solution distributed nationwide.
- Incorrect formulation may alter anticipated mydriatic, cycloplegic, or anti-inflammatory response, posing potential risks during ophthalmic procedures.
Fagron Sterile Services has voluntarily recalled one lot of its Tropicamide 1% / Cyclopentolate 1% / Phenylephrine 2.5% / Ketorolac 0.5% topical ophthalmic solution, supplied in 0.5 mL single-use syringes. The affected lot, C274-000047958 with an expiration date of December 19, 2025, includes 2980 syringes distributed throughout the United States. The product is intended for topical ophthalmic use only and is not for intravenous administration.
The recall was initiated due to an incorrect product formulation, which may lead to subtherapeutic or supratherapeutic concentrations of one or more active ingredients. For ophthalmic use—particularly during diagnostic dilation or preoperative preparation—unexpected potency changes may impact pupil dilation, cycloplegia, hemostasis, or inflammation control. Although the recall is classified as Class II, indicating a potentially reversible or medically manageable risk, pharmacists should be aware of the implications for patient safety and procedural outcomes.
The US Food and Drug Administration (FDA) lists this recall under Event ID 98040, with the recall formally initiated on November 20, 2025, and classified on December 8, 2025. Notification to consignees was issued by letter, and no public press release has been published. The recall remains ongoing, with Fagron Sterile Services serving as the responsible recalling firm. Distribution of the affected syringes occurred nationwide across the US.
This compounded ophthalmic combination is used to induce mydriasis and cycloplegia, provide vasoconstriction, and deliver anti-inflammatory analgesic effects—commonly employed in ophthalmic examinations, diagnostic dilation, and perioperative ocular procedures.
Reference
FDA. Enforcement Report. December 17, 2025. Accessed December 18, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm
