norepinephrine Bitartrate — Class II drug recall D-0438-2026
Ongoing recall by Fagron Compounding Services, reported 2026-04-15, distributed nationwide. Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
| Recall number | D-0438-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fagron Compounding Services, Wichita, KS, United States |
| Recall initiated | 2026-03-20 |
| Classified | 2026-04-07 |
| Reported by FDA | 2026-04-15 |
| Distributed | Nationwide (US) |
| Quantity | 25,260 bags |
| Reason classes | sterility, device malfunction |
| NDC | 71266-5026-02 |
| Lot numbers | C274-000049934, C274-000049963, C274-000050074, C274-000050123, C274-000050296, C274-000050420, C274-000050774, C274-000050924, C274-000050961, C274-000050991, C274-000051139, C274-000051166, C274-000051198, C274-000051343 |
| Expiration dates | 2026-04-23, 2026-04-24, 2026-04-30, 2026-05-01, 2026-05-09, 2026-05-16, 2026-06-05, 2026-06-11, 2026-06-12, 2026-06-19, 2026-06-20, 2026-06-21, 2026-06-28 |
Product
norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02
Reason for recall
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
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-0438-2026. 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.