Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Leukine sargramostim 5 x 500 mcg/mL vial Recalled by Bayer HealthCare Pharmaceuticals Inc. Due to Impurities/Degradation Products: A confirmed out of specification result...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bayer HealthCare Pharmaceuticals Inc. directly.
Affected Products
Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2
Quantity: 138,505 vials
Why Was This Recalled?
Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report