thiamine HCl — Class II drug recall D-0335-2026
Ongoing recall by Fresenius Kabi Compounding, LLC, reported 2026-02-18, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0335-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi Compounding, LLC, Canton, MA, United States |
| Recall initiated | 2026-02-05 |
| Classified | 2026-02-13 |
| Reported by FDA | 2026-02-18 |
| Distributed | Nationwide (US) |
| Quantity | 10,548 bags |
| Reason classes | sterility |
| NDC | 71506-0079-56 |
| Lot numbers | C274-000047651, C274-000048671, C274-000048828, C274-000049121, C274-000049127, C274-000049252, C274-000049260, C274-000049401, C274-000049413, C274-000049571, C274-000049581, C274-000049584, C274-000049717, C274-000049727 |
| Expiration dates | 2026-02-07, 2026-03-30, 2026-04-07, 2026-04-19, 2026-04-21, 2026-04-26, 2026-04-28, 2026-05-03, 2026-05-05, 2026-05-10, 2026-05-12, 2026-05-13, 2026-05-17, 2026-05-18 |
Product
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
Reason for recall
Lack of Assurance of Sterility
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-0335-2026. 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.