FDA recall, , Moderate risk
Fresenius Kabi Acyclovir, Ketamine, Thiamine and Vancomycin Injections
Acyclovir sodium, ketamine HCl, thiamine HCl, and vancomycin HCl injections lack assurance of sterility.
Summary by Recall Canary from the FDA notice
What happened
Fresenius Kabi Compounding, LLC of Canton, Massachusetts recalled acyclovir sodium, ketamine HCl, thiamine HCl, and vancomycin HCl injections due to lack of assurance of sterility. The recall began February 5, 2026, and the FDA added it to its Enforcement Report on February 12, 2026. The products were distributed nationwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
5 products
Match the list below, then check the codes the FDA notice also names.
A UPC is the number printed under a barcode.
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services
- UPC
- 000049628
- Lot code
- C274-000049628
thiamine HCl
- Strength
- 500 mg
- UPC
- 000047651
- 000048671
- 000048828
- 000049121
- 000049127
- 000049252
- 000049260
- 000049401
- 000049413
- 000049571
- 000049581
- 000049584
- 000049717
- 000049727
- Lot code
- 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
ketamine HCl, 1
- Strength
- 000 mg
- UPC
- 000047883
- 000048515
- 000048679
- 000049119
- 000049282
- Lot code
- C274-000047883
- C274-000048515
- C274-000048679
- C274-000049119
- C274-000049282
vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services
- UPC
- 000047611
- 000049633
- Lot code
- C274-000047611
- C274-000049633
acyclovir sodium
- Strength
- 200 mg
- UPC
- 000049124
- Lot code
- C274-000049124
From the FDA notice
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.
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- Fresenius Kabi Compounding, LLCCanton, Massachusetts
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98391
- Recall numbers
- D-0333-2026 to D-0337-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
