FDA-Drug2026-02-18Class IIPROCESSING DEFECT
Fresenius Kabi thiamine HCl injection recalled for sterility assurance
What this means
Fresenius Kabi Compounding has recalled multiple lots of thiamine HCl 500 mg injection because the manufacturer cannot confirm the product is sterile. This injectable medication was distributed nationwide. The recall affects 10,548 bags with expiration dates between February and May 2026.
- Stop using any thiamine HCl 500 mg injection with lot numbers C274-000047651 through C274-000049727 and expiration dates between 7-Feb-26 and 18-May-26.
- Contact your pharmacy or healthcare provider immediately if you have received this product.
- Do not discard the medication; return it to your pharmacy or healthcare facility for proper disposal.
- Ask your provider about alternative thiamine sources if you need this vitamin.
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
10,548 bags
Manufactured in
20 Dan Rd, N/A, Canton, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0335-2026Want us to check the next one for you?
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