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Lower risk Drug recall · FDA · Published June 29, 2020

Cetrotide 0.25mg Injection Recall: Missing Stoppers Risk Contamination

EMD Serono recalls Cetrotide 0.25mg injections due to missing rubber stoppers that could compromise sterility. Affected lots from 2020 with specific NDC and expiration dates.

🇺🇸 FDA recall #D-1379-2020DrugEMD Serono ›
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Recalling firmEMD Serono, Inc.1 Technology Pl · Rockland, MA 02370-1071
✎ GovInfoNow plain-language explainer

What happened, in plain English

EMD Serono is recalling Cetrotide 0.25mg injections because some vials may have missing rubber stoppers. This could lead to contamination and infection if the medication is not properly sterile. Read more at govinfonow.com/recall/36994-cetrotide-0-25mg-injection-recall-missing-stoppers-risk-contamination.

Source Summary by GovInfoNow · govinfonow.com/recall/36994-cetrotide-0-25mg-injection-recall-missing-stoppers-risk-contamination · Updated October 5, 2026 · FDA enforcement record: FDA #D-1379-2020

Cite this page

“Cetrotide 0.25mg Injection Recall: Missing Stoppers Risk Contamination.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/36994-cetrotide-0-25mg-injection-recall-missing-stoppers-risk-contamination. Based on FDA recall #D-1379-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1379-2020%22&limit=1).

Why it’s dangerous

Missing rubber stoppers in the vial can cause the medication to become contaminated. This could lead to infection or other health issues if the injection is not properly sterile.

Who’s affected

People with prescriptions for Cetrotide 0.25mg injections. Those who have the specific lot numbers and expiration date mentioned in the recall are most at risk.

How to tell if you have this one

Check the vial for missing rubber stoppers. The affected product has NDC 44087-1225-1, lot numbers 8J025A or 8J025B, and expires September 30, 2020.

  • Brand
    EMD Serono
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Vial for Stoppers

    Inspect the vial for missing rubber stoppers, which could compromise sterility.

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: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

1. Firm started the recall: Jun 29, 202012. FDA classified it Class II: Jul 8, 202023. Published in FDA’s Enforcement Report: Jul 15, 202034. FDA terminated the recall: Mar 11, 2022420202022
  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-1379-2020 (June 29, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1379-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 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