Class II · Moderate risk
Thiamine HCl 0.9% Sodium Chloride Injection USP
cGMP violations
thiamine HCl
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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.
Affected NDC
71506-0079-56
Compare with the code on your package — it is the most precise check available.
Drug: Thiamine
- Recalling firm
- Fresenius Kabi Compounding, LLC
- NDC code
- 71506-079-56
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0335-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Thiamine recalls
See all
Class II · Moderate risk
Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution
Presence of Particulate Matter.
Class II · Moderate risk
B-Complex
Presence of Particulate Matter.
Class II · Moderate risk
Thiamine/Ribofla/Niacinami/Dexpanth/Pyridox/Hydroxycobal 25mg/25mg/25mg/25mg/25mg/20mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Thiamine Hydrochloride 3000 mg/30 mL
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Other recalls by Fresenius Kabi Compounding, LLC
All 2026 recalls
Class II · Moderate risk
vancomycin HCl
Lack of Assurance of Sterility
Class II · Moderate risk
vancomycin HCl
Lack of Assurance of Sterility
Class II · Moderate risk
ketamine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
acyclovir sodium
Lack of Assurance of Sterility
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