CLASS III ONGOING Drug recall · Reported 6 Dec 2023 · FDA Enforcement Report
Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL) recalled
Fagron Compounding Services is recalling Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), distributed nationwide in the US. The recall was initiated on 10 Nov 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0125-2024
- FDA event ID
- 93453
- Recalling firm
- Fagron Compounding Services, Wichita, KS
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 10 Nov 2023
- FDA classified
- 28 Nov 2023
- Reported
- 6 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 10 Nov 2023 | Recall initiated by company | |
| 28 Nov 2023 | Classified by FDA | +18 days |
| 6 Dec 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug, Hospital & Office Use Only, Fagron Sterile Services, 8710 E 34th St N Wichita, KS 67226. NDC 71266-8240-01
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot #: C274-000033372, Exp. Date 01-17-2024; C274-000033764, Exp. Date 02-06-2024
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fagron Compounding Services
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vancomycin HCL added to, 0.9% Sodium Chloride Injection recalled | Fagron Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | norepinephrine Bitartrate,16mg per 0.9% Sodium Chloride recalled | Fagron Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | norepinephrine Bitartrate, 32mg per 0.9% Sodium Chloride recalled | Fagron Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | Vancomycin HCI added to, 0.9% Sodium Chloride Injection recalled | Fagron Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | Vancomycin HCI added to, 0.9% Sodium Chloride Injection recalled | Fagron Compounding Services | Sterility | Nationwide |
Other Tropicamide recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tropicamide 1%/Cyclopentolate 1%/Phenylephrine recalled | Fagron Compounding Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Tropicamide Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Tropicamide Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Tropicamide Ophthalmic Solution recalled by Mckesson Medical-Surgical | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Tropicamide Ophthalmic Solution recalled by Bausch & LombTropicamide | Bausch & Lomb | Packaging Defects | Nationwide |