Tropicamide 1% — Class III drug recall D-0125-2024
Ongoing recall by Fagron Compounding Services, reported 2023-12-06, distributed nationwide. Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use sy
| Recall number | D-0125-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fagron Compounding Services, Wichita, KS, United States |
| Recall initiated | 2023-11-10 |
| Classified | 2023-11-28 |
| Reported by FDA | 2023-12-06 |
| Distributed | Nationwide (US) |
| Quantity | 756 bottles |
| Reason classes | labeling |
| NDC | 71266-8240-01 |
| Lot numbers | C274-000033372, C274-000033764 |
| Expiration dates | 2024-01-17, 2024-02-06 |
Product
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
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
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-0125-2024. 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.