Thiamine injection bags recalled over a lack of assurance of sterility
Fresenius Kabi Compounding is recalling 10,548 bags of thiamine HCl 500 mg in sodium chloride injection over a lack of assurance of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: sterility cannot be assured for a product given intravenously, and no injuries are reported.
Plain-English summary
Thiamine HCl, 500 mg added to 100 mL of 0.9% Sodium Chloride Injection, USP, prepared by Fagron Sterile Services of Canton, Massachusetts, under NDC 71506-079-56, is being recalled by Fresenius Kabi Compounding, LLC.
The reason given in the enforcement record is a lack of assurance of sterility.
The record lists 10,548 bags from lots C274-000047651 (expiry 7-Feb-26) and C274-000048671 (expiry 30-Mar-26), among the lots recorded in the enforcement record. Distribution was nationwide in the US. The FDA has classified the action as Class II.
Sterility that cannot be assured in a product given intravenously carries an infection risk. The record reports no injuries. Facilities should quarantine affected lots and follow the firm's instructions.
The recalled product
- 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.
- Manufacturer
- Fresenius Kabi Compounding, LLC
- Category
- Drug — Compounded injection
- Affected units
- 10,548
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot # C274-000047651
- Exp Date: 7-Feb-26
- Lot # C274-000048671
- Exp Date: 30-Mar-26
- Lot # C274-000048828
- Exp Date: 7-Apr-26
- Lot # C274-000049121
- Exp Date: 19-Apr-26
- Lot # C274-000049127
- Exp Date: 21-Apr-26
- Lot # C274-000049252
- Exp Date: 26-Apr-26
- Lot # C274-000049260
- Exp Date: 28-Apr-26
- Lot # C274-000049401
- Exp Date: 3-May-26
- Lot # C274-000049413
- Exp Date: 5-May-26
- Lot # C274-000049571
- Exp Date: 10-May-26
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Fresenius Kabi Compounding, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Fresenius Kabi Compounding, LLC
See all →- HighVancomycin injection bags recalled over a lack of assurance of sterility
FDA (Drugs) · 2026-02-18
- HighAcyclovir injection bags recalled over a lack of assurance of sterility
FDA (Drugs) · 2026-02-18
- HighKetamine injection bags recalled over a lack of assurance of sterility
FDA (Drugs) · 2026-02-18
- HighVancomycin 2 gram bags recalled over a lack of assurance of sterility
FDA (Drugs) · 2026-02-18
- HighPhenylephrine HCl Injectable Drug Recalled for Manufacturing Practice Violations
FDA (Drugs) · 2024-10-30
Same hazard · sterility assurance
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
- SevereArrow drainage and thoracentesis kits contain recalled supplier drugs
FDA (Devices) · 2026-06-24