Leukine sargramostim 5 x 500 mcg/mL vial — Class III drug recall D-156-2013
Terminated recall by Bayer HealthCare Pharmaceuticals Inc., reported 2013-02-13, distributed nationwide. Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 o
| Recall number | D-156-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer HealthCare Pharmaceuticals Inc., Lynnwood, WA, United States |
| Recall initiated | 2012-05-31 |
| Classified | 2013-02-07 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2013-05-10 |
| Distributed | Nationwide (US) |
| Quantity | 138,505 vials |
| Reason classes | specification failure |
| NDC | 58468-0181-02 |
Product
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
Reason for recall
Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-156-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.