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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Fresenius Kabi Sterile Injectable Drugs Recalled for Lack of Sterility

Agency Publication Date: February 12, 2026
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Summary

Fresenius Kabi Compounding, LLC is recalling 14,593 bags of various sterile injectable medications including ketamine, acyclovir, thiamine, and vancomycin. The recall was initiated because the products lack assurance of sterility, which means they may not be completely free of microorganisms. These medications are administered intravenously in clinical or hospital settings and were distributed nationwide across the United States.

Risk

Administering a drug intended to be sterile that is contaminated with microorganisms could lead to serious, life-threatening infections, particularly in vulnerable patients. No specific injuries or infections have been reported to date, but the lack of sterility assurance poses a significant safety risk during intravenous use.

What You Should Do

  1. Identify if you have any of the affected products by checking the brand name 'Fagron Sterile Services' and the specific drug names: ketamine HCl, acyclovir sodium, thiamine HCl, or vancomycin HCl.
  2. Check the lot numbers and expiration dates on the medication bags. Affected lots include C274-000047883, C274-000049124, C274-000047651, C274-000049628, and many others. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately.
  4. Contact the manufacturer or your distributor to arrange for the return of any remaining inventory.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: ketamine HCl in Sodium Chloride Injection (1,000 mg per 100 mL)by Fagron Sterile Services
Variants: 10 mg per mL, 100 mL Bag
Lot Numbers:
C274-000047883 (Exp Date: 17-Feb-26)
C274-000048515 (Exp Date: 22-Mar-26)
C274-000048679 (Exp Date: 31-Mar-26)
C274-000049119 (Exp Date: 19-Apr-26)
C274-000049282 (Exp Date: 27-Apr-26)
NDC:
71506-050-56

Recall #: D-0334-2026; Quantity: 1410 bags

Product: acyclovir sodium in 0.9% Sodium Chloride Injection, USP (200 mg per 100 mL)by Fagron Sterile Services
Variants: Single-Use Bag, 100 mL Bag
Lot Numbers:
C274-000049124 (Exp Date: 28-Feb-26)
NDC:
71506-035-56

Recall #: D-0333-2026; Quantity: 1057 bags

Product: thiamine HCl in 0.9% Sodium Chloride Injection, USP (500 mg per 100 mL)by Fagron Sterile Services
Variants: 100 mL Bag
Lot Numbers:
C274-000047651 (Exp Date: 7-Feb-26)
C274-000048671 (Exp Date: 30-Mar-26)
C274-000048828 (Exp Date: 7-Apr-26)
C274-000049121 (Exp Date: 19-Apr-26)
C274-000049127 (Exp Date: 21-Apr-26)
C274-000049252 (Exp Date: 26-Apr-26)
C274-000049260 (Exp Date: 28-Apr-26)
C274-000049401 (Exp Date: 3-May-26)
C274-000049413 (Exp Date: 5-May-26)
C274-000049571 (Exp Date: 10-May-26)
C274-000049581 (Exp Date: 12-May-26)
C274-000049584 (Exp Date: 13-May-26)
C274-000049717 (Exp Date: 17-May-26)
C274-000049727 (Exp Date: 18-May-26)
NDC:
71506-079-56

Recall #: D-0335-2026; Quantity: 10,548 bags

Product: vancomycin HCl in 0.9% Sodium Chloride Injection, USP (1.5 grams per 500 mL)by Fagron Sterile Services
Variants: 500 mL Bag
Lot Numbers:
C274-000049628 (Exp Date: 3-May-26)
NDC:
71506-016-59

Recall #: D-0336-2026; Quantity: 1578 bags

Product: vancomycin HCl in 0.9% Sodium Chloride Injection, USP (2 grams per 500 mL)by Fagron Sterile Services
Variants: 500 mL Bag
Lot Numbers:
C274-000047611 (Exp Date: 10-Feb-26)
C274-000049633 (Exp Date: 12-May-26)
NDC:
71506-019-59

Recall #: D-0337-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98391
Status: Active
Manufacturer: Fresenius Kabi Compounding, LLC
Sold By: Hospitals; Infusion centers; Clinical facilities
Manufactured In: United States
Units Affected: 4 products (1057 bags; 1410 bags; 10,548 bags; 1578 bags)
Distributed To: Nationwide
Agency Last Updated: February 13, 2026

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.