FDA Drug recall D-0225-2025
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N,…
- FDA Drug
- Class II
- completed
- Published 2025-02-26
On 2025-02-26 the FDA classified a Class II recall of fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N,… by Fagron Compounding Services, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0225-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2025-01-31 |
| Published | 2025-02-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fagron Compounding Services |
| Distribution | PA |
Product
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot # C274-000040409, Exp 03/22/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Other recalls by Fagron Compounding Services
- norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226,…
FDA Drug · Class II · 2026-04-15 · Fagron Compounding Services - Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, ND…
FDA Drug · Class II · 2026-04-15 · Fagron Compounding Services - Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226…
FDA Drug · Class II · 2026-04-15 · Fagron Compounding Services - norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, N…
FDA Drug · Class II · 2026-04-15 · Fagron Compounding Services - Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226,…
FDA Drug · Class II · 2026-04-15 · Fagron Compounding Services
All Fagron Compounding Services recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0225-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.