--- title: "Fresenius Kabi Compounding, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Fresenius Kabi Compounding, LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/fresenius-kabi-compounding-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Feb 5, 2026 FDA 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...](https://isitonrecall.com/recall/fda-drug-d-0333-2026-acyclovir-sodium-200-mg-200mg-added-to-100-ml-0-9-sodium-chloride-injection-usp-for-intravenous-use/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide. [Official source for acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intrave...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0333-2026%22) Feb 5, 2026 FDA 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](https://isitonrecall.com/recall/fda-drug-d-0334-2026-ketamine-hcl-1-000-mg-1-000-mg-per-100-ml-10-mg-per-ml-in-sodium-chloride-injection-fagron-sterile-s/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide. [Official source for ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron S...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0334-2026%22) Feb 5, 2026 FDA 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.](https://isitonrecall.com/recall/fda-drug-d-0335-2026-thiamine-hcl-500-mg-500-mg-added-to-100-ml-0-9-sodium-chloride-injection-usp-fagron-sterile-services/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide. [Official source for thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0335-2026%22) Feb 5, 2026 FDA 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](https://isitonrecall.com/recall/fda-drug-d-0336-2026-vancomycin-hcl-1-5-grams-1-5-grams-added-to-500-ml-0-9-sodium-chloride-injection-usp-fagron-sterile/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide. [Official source for vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0336-2026%22) Feb 5, 2026 FDA 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.](https://isitonrecall.com/recall/fda-drug-d-0337-2026-vancomycin-hcl-2-grams-2-grams-added-to-500-ml-0-9-sodium-chloride-injection-usp-fagron-sterile-serv/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide. [Official source for vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Ste...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0337-2026%22) Sep 25, 2024 FDA 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](https://isitonrecall.com/recall/fda-drug-d-0014-2025-phenylephrine-hcl-0-9-sodium-chloride-injection-usp-20-mg-per-250-ml-single-dose-bag-rx-only-fagron/) CGMP violations Class II Reported terminated Distribution: Product was distributed to 125 direct accounts nationwide. [Official source for Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0014-2025%22) Sep 25, 2024 FDA 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](https://isitonrecall.com/recall/fda-drug-d-0015-2025-phenylephrine-hcl-0-9-sodium-chloride-injection-usp-20-mg-per-250-ml-single-dose-bag-rx-only-fagron/) cGMP violations Class II Reported terminated Distribution: Product was distributed to 125 direct accounts nationwide. [Official source for Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0015-2025%22) Sep 25, 2024 FDA 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](https://isitonrecall.com/recall/fda-drug-d-0016-2025-phenylephrine-hcl-0-9-sodium-chloride-injection-usp-10-mg-per-250-ml-single-dose-bag-rx-only-fagron/) cGMP violations Class II Reported terminated Distribution: Product was distributed to 125 direct accounts nationwide. [Official source for Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0016-2025%22) Sep 25, 2024 FDA 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](https://isitonrecall.com/recall/fda-drug-d-0017-2025-phenylephrine-hcl-0-9-sodium-chloride-injection-usp-10-mg-per-250-ml-single-dose-bag-rx-only-fagron/) cGMP violations Class II Reported terminated Distribution: Product was distributed to 125 direct accounts nationwide. [Official source for Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0017-2025%22) Sep 25, 2024 FDA 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](https://isitonrecall.com/recall/fda-drug-d-0018-2025-vancomycin-hcl-750-mg-per-250-ml-0-9-sodium-chloride-injection-usp-single-dose-bag-rx-only-fagron-st/) cGMP violations Class II Reported terminated Distribution: Product was distributed to 125 direct accounts nationwide. [Official source for Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fa...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0018-2025%22) Sep 25, 2024 FDA 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](https://isitonrecall.com/recall/fda-drug-d-0019-2025-norepinephrine-bitartrate-0-9-sodium-chloride-injection-usp-4-mg-per-250-ml-single-dose-bag-rx-only/) cGMP violations Class II Reported terminated Distribution: Product was distributed to 125 direct accounts nationwide. [Official source for NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, R...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0019-2025%22) Sep 25, 2024 FDA 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](https://isitonrecall.com/recall/fda-drug-d-0020-2025-norepinephrine-bitartrate-0-9-sodium-chloride-injection-usp-8-mg-per-250-ml-single-dose-bag-rx-only/) cGMP violations Class II Reported terminated Distribution: Product was distributed to 125 direct accounts nationwide. [Official source for NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, R...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0020-2025%22) Sep 25, 2024 FDA 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](https://isitonrecall.com/recall/fda-drug-d-0021-2025-oxytocin-0-9-sodium-chloride-injection-usp-30-units-per-500-ml-single-dose-bag-rx-only-fagron-steril/) cGMP violations Class II Reported terminated Distribution: Product was distributed to 125 direct accounts nationwide. [Official source for Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0021-2025%22) Sep 25, 2024 FDA 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](https://isitonrecall.com/recall/fda-drug-d-0022-2025-epinephrine-0-9-sodium-chloride-injection-usp-8-mg-per-250-ml-single-dose-bag-rx-only-fagron-sterile/) cGMP violations Class II Reported terminated Distribution: Product was distributed to 125 direct accounts nationwide. [Official source for EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0022-2025%22) Sep 25, 2024 FDA 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](https://isitonrecall.com/recall/fda-drug-d-0023-2025-thiamine-hcl-0-9-sodium-chloride-injection-usp-500-mg-per-100-ml-single-dose-bag-rx-only-fagron-ster/) cGMP violations Class II Reported terminated Distribution: Product was distributed to 125 direct accounts nationwide. [Official source for Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fag...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0023-2025%22) ## 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. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/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. ## Keep checking [Search Fresenius Kabi Compounding, LLC](https://isitonrecall.com/check/?q=Fresenius%20Kabi%20Compounding%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)