Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2 — Class II drug recall D-0221-2026
Ongoing recall by Fagron Compounding Services, reported 2025-12-17, distributed nationwide. Incorrect Product Formulation
| Recall number | D-0221-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fagron Compounding Services, Wichita, KS, United States |
| Recall initiated | 2025-11-20 |
| Classified | 2025-12-08 |
| Reported by FDA | 2025-12-17 |
| Distributed | Nationwide (US) |
| Quantity | 2,980 syringes |
| NDC | 71266-8240-01 |
| Lot numbers | C274-000047958 |
| Expiration dates | 2025-12-19 |
Product
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
Reason for recall
Incorrect Product Formulation
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0221-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.