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DRUG RECALLMODERATE
Thiamine HCl Injection 500 mg/100 mL
Fresenius Kabi recalls thiamine HCl 500 mg/100 mL IV bags over sterility concerns.
What to do
Do not use the recalled product. Contact Fresenius Kabi Compounding for return and replacement instructions.
Why it was recalled
Fresenius Kabi Compounding is recalling thiamine HCl 500 mg added to 100 mL 0.9% Sodium Chloride Injection, USP, single-use bags, due to a lack of assurance of sterility. The affected product is NDC 71506-079-56.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | Strength | UPC | Recall # |
|---|---|---|---|
| vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20… | – | 000049628 | D-0336-2026 |
| thiamine HCl | 500 mg | 000047651, 000048671, 000048828, 000049121, 000049127, 000049252, 000049260, 000049401, 000049413, 000049571, 000049581, 000049584, 000049717, 000049727 | D-0335-2026 |
| ketamine HCl, 1 | 000 mg | 000047883, 000048515, 000048679, 000049119, 000049282 | D-0334-2026 |
| vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan… | – | 000047611, 000049633 | D-0337-2026 |
| acyclovir sodium | 200 mg | 000049124 | D-0333-2026 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
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Editorial summary by Recall Canary · summary updated 2026-07-30 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification