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Stop using now Drug recall · FDA · Published September 17, 2021

Fresenius Kabi Morphine Sulfate Injection Recall: Cracked Vials Risk Contamination

Fresenius Kabi recalls Morphine Sulfate Injection vials with cracked containers that may cause contamination. Affected lots expire 03/2023 or 06/2023. Stop using and contact for replacement.

🇺🇸 FDA recall #D-0856-2021DrugFresenius Kabi ›
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Recalling firmFresenius Kabi USA LLC2020 N Ruby St · Melrose Park, IL 60160-1112
✎ GovInfoNow plain-language explainer

What happened, in plain English

Fresenius Kabi is recalling Morphine Sulfate Injection vials that can crack, risking contamination. This is serious because contaminated medication could cause infection or other health issues. Read more at govinfonow.com/recall/35852-fresenius-kabi-morphine-sulfate-injection-recall-cracked-vials-risk-contamination.

Source Summary by GovInfoNow · govinfonow.com/recall/35852-fresenius-kabi-morphine-sulfate-injection-recall-cracked-vials-risk-contamination · Updated August 18, 2026 · FDA enforcement record: FDA #D-0856-2021

Cite this page

“Fresenius Kabi Morphine Sulfate Injection Recall: Cracked Vials Risk Contamination.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35852-fresenius-kabi-morphine-sulfate-injection-recall-cracked-vials-risk-contamination. Based on FDA recall #D-0856-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0856-2021%22&limit=1).

Why it’s dangerous

Cracked vials can lead to loss of sterility, meaning the medication may become contaminated. This contamination could cause infections or other health problems if the medication is used.

Who’s affected

Prescribers and patients using this specific morphine injection for pain management. Those with the recalled vial lot numbers are most at risk.

How to tell if you have this one

Check for vials with lot numbers 6023731, 6023732 (expiring 03/2023) or 6024172, 6024260 (expiring 06/2023). The product is a 1 mL single-dose vial for prescription use.

  • Brand
    Fresenius Kabi
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Vial Now

    Immediately discard any vial with lot numbers 6023731, 6023732, 6024172, or 6024260.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “U.S.A. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: Sep 17, 202112. FDA classified it Class II: Sep 27, 202123. Published in FDA’s Enforcement Report: Oct 6, 202134. FDA terminated the recall: Jun 20, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0856-2021 (September 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0856-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA