Partner Therapeutics LEUKINE injection recall: Stability issue in 250 mcg vials
Partner Therapeutics recalls LEUKINE (sargramostim) 250 mcg vials due to stability failure at 27 months. This may affect patients using the product for cancer treatment.
Lower-risk recall
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
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What happened, in plain English
Partner Therapeutics is recalling LEUKINE (sargramostim) 250 mcg vials because they failed stability tests at 27 months. This could mean the product might not work properly for cancer treatment patients. Read more at govinfonow.com/recall/36108-partner-therapeutics-leukine-injection-recall-stability-issue-in-250-mcg.
Source Summary by GovInfoNow · govinfonow.com/recall/36108-partner-therapeutics-leukine-injection-recall-stability-issue-in-250-mcg · Updated August 18, 2026 · FDA enforcement record: FDA #D-0655-2021
Cite this page
“Partner Therapeutics LEUKINE injection recall: Stability issue in 250 mcg vials.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36108-partner-therapeutics-leukine-injection-recall-stability-issue-in-250-mcg. Based on FDA recall #D-0655-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0655-2021%22&limit=1).
Why it’s dangerous
The product failed stability tests at 27 months, meaning it may not be effective for cancer treatment. This could lead to treatment failure if the medication doesn't work as intended.
Who’s affected
Patients prescribed LEUKINE for cancer treatment who have the specific vial size and lot number. Those using the product without a doctor's prescription are not affected.
How to tell if you have this one
Check for LEUKINE (sargramostim) 250 mcg vials in 5mL size, 5 vials per box, with lot number E8023E and expiration date 11/30/2022. This product is only available by prescription.
- Brand
Partner Therapeutics- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the vial packaging to confirm if it matches the recalled batch.
How this recall unfolded
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- 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-0655-2021 (June 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0655-2021 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.