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Use caution Drug recall · FDA · Published May 31, 2012

Bayer Recalls Leukine Sargramostim Vials Due to Impurities

Bayer recalls specific lots of Leukine sargramostim vials due to confirmed impurities and degradation products found at the three-month time point.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-156-2013DrugBayer ›
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Recalling firmBayer HealthCare Pharmaceuticals Inc.2625 162nd St SW · Lynnwood, WA 98087
✎ GovInfoNow plain-language explainer

Bayer HealthCare Pharmaceuticals is recalling specific lots of Leukine sargramostim, a sterile liquid injection. The recall was initiated because testing confirmed out-of-specification results for impurities or degradation products in lot B18827 at the three-month time point. This affects 138,505 vials distributed nationwide. Read more at govinfonow.com/recall/48679-bayer-healthcare-pharmaceuticals-inc-recalls-leukine-sargramostim-5-x-500.

Source Summary by GovInfoNow · govinfonow.com/recall/48679-bayer-healthcare-pharmaceuticals-inc-recalls-leukine-sargramostim-5-x-500 · Updated October 13, 2026 · FDA enforcement record: FDA #D-156-2013

Cite this page

“Bayer Recalls Leukine Sargramostim Vials Due to Impurities.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48679-bayer-healthcare-pharmaceuticals-inc-recalls-leukine-sargramostim-5-x-500. Based on FDA recall #D-156-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-156-2013%22&limit=1).

The FDA announced on 2012-05-31 that Bayer HealthCare Pharmaceuticals Inc. is recalling Leukine sargramostim vials due to impurities and degradation products found in lot B18827. The recall involves 138,505 vials distributed nationwide.

How to tell if you have it

  • Brand: Bayer
  • Product: Leukine Sargramostim Vial
  • Lot codes: B18511, B18513, B18515, B18517, B18825, B18831, B18827
  • Expiration dates: 04/12, 05/12, 06/12, 06/12, 10/12, 12/12
  • NDC: 58468-0181-2
  • Quantity: 138,505 vials

The hazard

A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point. The hazard is identified as impurities and degradation products.

Context

GovInfoNow's records show Bayer Healthcare Pharmaceuticals Inc. has 9 other recalls on record since 2012-05-08. Other recent recalls of similar products include Bayer VITRAKVI oral solution recall (2023-11-06) and Bayer Lotrimin AF Deodorant Powder Spray Recall (2021-10-01). Additional context includes a Bayer Alka-Seltzer Plus label mix-up risk recall on 2018-03-15, a Bayer 25-count tablets recall due to sanitation risks on 2025-12-26, and recalls of similar injectable products by Fresenius Kabi (2026-05-14) and Sagent (2026-05-04).

How to tell if you have this one

Check your vials for the following details: Product name Leukine sargramostim, NDC 58468-0181-2, and Lot numbers B18511 (Exp. 04/12), B18513 (Exp. 05/12), B18515 (Exp. 06/12), B18517 (Exp. 06/12), B18825 (Exp. 10/12), B18831 (Exp. 12/12), and B18827.

  • Brand
    Bayer
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Contact Your Healthcare Provider

    Speak with your doctor or pharmacist about the recall and how to proceed with your specific prescription, as the remedy is not explicitly stated in this record.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: May 31, 201212. FDA classified it Class III: Feb 7, 201323. Published in FDA’s Enforcement Report: Feb 13, 201334. FDA terminated the recall: May 10, 2013420122013
  1. Firm started the recall
  2. FDA classified it Class III
  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-156-2013 (May 31, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-156-2013 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 13, 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