CLASS II ONGOING Drug recall · Reported 17 Dec 2025 · FDA Enforcement Report
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine recalled
Fagron Compounding Services is recalling Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic, distributed nationwide in the US. The recall was initiated on 20 Nov 2025 and the FDA has classified it as Class II.
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-0221-2026
- FDA event ID
- 98040
- Recalling firm
- Fagron Compounding Services, Wichita, KS
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Nov 2025
- FDA classified
- 8 Dec 2025
- Reported
- 17 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 20 Nov 2025 | Recall initiated by company | |
| 8 Dec 2025 | Classified by FDA | +18 days |
| 17 Dec 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect Product Formulation
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%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01
Where it was distributed
U.S. Nationwide.
Questions about this recall
Why was it recalled?
Incorrect Product Formulation
Which lots are affected?
Lot#: C274-000047958; Exp. December 19, 2025
Where was it sold?
U.S. Nationwide.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 III | Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL) 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 |