Fagron Compounding Services recalls Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL
Fagron recalls 5mL eye drop bottles with incorrect labeling that may confuse use as single-use syringes. This could lead to improper use if mistaken for a different container.
Lower-risk recall
Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
Contact the company & request your remedy
What happened, in plain English
Fagron Compounding Services has recalled certain eye drop bottles due to a labeling error. The label mistakenly states these are single-use syringes instead of 5mL droppers. This could cause confusion about how to use the product safely. Read more at govinfonow.com/recall/32972-fagron-tropicamide-1-eye-drops-label-mix-up-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32972-fagron-tropicamide-1-eye-drops-label-mix-up-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0125-2024
Cite this page
“Fagron Tropicamide 1% Eye Drops: Label Mix-Up Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32972-fagron-tropicamide-1-eye-drops-label-mix-up-risk. Based on FDA recall #D-0125-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0125-2024%22&limit=1).
Why it’s dangerous
The label incorrectly identifies the 5mL dropper bottle as a single-use syringe. This could lead to confusion about the correct usage, but the product is designed for eye drops and not for injection.
Who’s affected
People who purchased the recalled eye drops for eye use, particularly those in hospitals or clinics. The risk is low as the product is for topical ophthalmic use only.
How to tell if you have this one
Check for the label stating the container is a 0.5mL single-use syringe instead of a 5mL dropper. The product is for topical ophthalmic use only and not for IV use.
- Brand
Fagron- Category
Drug
What to do — step by step
Check Label
Look for the label that mistakenly states the container is a 0.5mL single-use syringe instead of a 5mL dropper.
Questions people ask
Is this product safe to use?
The product is safe for topical ophthalmic use only, but the labeling error could cause confusion about proper usage.
What should I do if I have this product?
The official recall does not specify a remedy, so check the label and contact Fagron Compounding Services for further instructions.
How can I tell if I have the recalled product?
Look for the label that mistakenly states the container is a 0.5mL single-use syringe instead of a 5mL dropper.
Contact Fagron
We’ve drafted a message you can send Fagron to request your refund or repair — edit it as you like.
Subject: Recall D-0125-2024 — Fagron Fagron Hello, I own a Fagron that is covered by recall D-0125-2024 from Fagron. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0125-2024 (November 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0125-2024 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.