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Fresenius Kabi Compounding, LLC recall records

5 reported ongoing

15 records in this archive. Latest source date Feb 5, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

Feb 5, 2026FDA drug enforcement

acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021...

Lack of Assurance of Sterility

Class IIReported ongoing

Distribution: US Nationwide.

Official source

Feb 5, 2026FDA drug enforcement

ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56

Lack of Assurance of Sterility

Class IIReported ongoing

Distribution: US Nationwide.

Official source

Feb 5, 2026FDA drug enforcement

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.

Lack of Assurance of Sterility

Class IIReported ongoing

Distribution: US Nationwide.

Official source

Feb 5, 2026FDA drug enforcement

vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59

Lack of Assurance of Sterility

Class IIReported ongoing

Distribution: US Nationwide.

Official source

Feb 5, 2026FDA drug enforcement

vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.

Lack of Assurance of Sterility

Class IIReported ongoing

Distribution: US Nationwide.

Official source

Sep 25, 2024FDA drug enforcement

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58

CGMP violations

Class IIReported terminated

Distribution: Product was distributed to 125 direct accounts nationwide.

Official source

Sep 25, 2024FDA drug enforcement

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58

cGMP violations

Class IIReported terminated

Distribution: Product was distributed to 125 direct accounts nationwide.

Official source

Sep 25, 2024FDA drug enforcement

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58

cGMP violations

Class IIReported terminated

Distribution: Product was distributed to 125 direct accounts nationwide.

Official source

Sep 25, 2024FDA drug enforcement

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58

cGMP violations

Class IIReported terminated

Distribution: Product was distributed to 125 direct accounts nationwide.

Official source

Sep 25, 2024FDA drug enforcement

Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58

cGMP violations

Class IIReported terminated

Distribution: Product was distributed to 125 direct accounts nationwide.

Official source

Sep 25, 2024FDA drug enforcement

NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58

cGMP violations

Class IIReported terminated

Distribution: Product was distributed to 125 direct accounts nationwide.

Official source

Sep 25, 2024FDA drug enforcement

NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58

cGMP violations

Class IIReported terminated

Distribution: Product was distributed to 125 direct accounts nationwide.

Official source

Sep 25, 2024FDA drug enforcement

Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59

cGMP violations

Class IIReported terminated

Distribution: Product was distributed to 125 direct accounts nationwide.

Official source

Sep 25, 2024FDA drug enforcement

EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58

cGMP violations

Class IIReported terminated

Distribution: Product was distributed to 125 direct accounts nationwide.

Official source

Sep 25, 2024FDA drug enforcement

Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56

cGMP violations

Class IIReported terminated

Distribution: Product was distributed to 125 direct accounts nationwide.

Official source

Reasons in these listed records

Lack of Assurance of Sterility
CGMP violations
cGMP violations

These examples come from this result page and are not a ranking of every recall reason.

Checking Fresenius Kabi Compounding, LLC

Is there a recall on fresenius kabi compounding, llc right now?

This archive contains 15 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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