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Drug FDA Class II Ongoing Contamination / non-sterility

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.

Fresenius Kabi Compounding, LLC Published Feb 18, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Fresenius Kabi Compounding, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility

Hazards

Lack of Assurance of Sterility · primary

Affected products (1)

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.

10,548 bags

Lot codes: 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
Code info: 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; Lot # C274-000049581, Exp Date: 12-May-26; Lot # C274-000049584, Exp Date: 13-May-26; Lot # C274-000049717, Exp Date: 17-May-26; Lot # C274-000049727, Exp Date: 18-May-26.

Affected areas

Nationwide

Timeline

  1. Initiated
    Feb 5, 2026
  2. Published
    Feb 18, 2026
Recall number
D-0335-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.