Mylan Institutional Inc recalls Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan
Mylan recalls 250 mg/25 mL Levoleucovorin Injection vials due to copper salts causing particulate matter. Affected vials have NDC 67457-601-30, lots APB032/033, expiring April 2019.
Recall notice
Presence of Particulate Matter: particulate matter identified as copper salts
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling Levoleucovorin Injection vials that may contain copper salts causing particulate matter. This could lead to serious health issues if the vials are used as intended. Read more at govinfonow.com/recall/39218-mylan-levoleucovorin-injection-recall-copper-particulate-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39218-mylan-levoleucovorin-injection-recall-copper-particulate-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1059-2019
Cite this page
“Mylan Levoleucovorin Injection Recall: Copper Particulate Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39218-mylan-levoleucovorin-injection-recall-copper-particulate-risk. Based on FDA recall #D-1059-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1059-2019%22&limit=1).
Why it’s dangerous
The vials may contain copper salts that create particulate matter. This can cause serious health issues if the medication is administered.
Who’s affected
Prescription patients using Levoleucovorin Injection for medical treatment. Those with the specific vial model and lot numbers are most at risk.
How to tell if you have this one
Check for NDC code 67457-601-30 and lot numbers APB032 or APB033. The vials expire April 2019 and were manufactured in India.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Vial Details
Look for NDC 67457-601-30 and lot numbers APB032 or APB033 on the vial label.
Questions people ask
Is this product safe to use?
The recall states the vials may contain copper salts causing particulate matter, so they should not be used until the remedy is followed.
What should I do if I have this product?
The recall does not specify a remedy, so contact Mylan for guidance on next steps.
How can I tell if I have the recalled vial?
Check for NDC code 67457-601-30 and lot numbers APB032 or APB033 on the vial label.
Contact Mylan
We’ve drafted a message you can send Mylan to request your refund or repair — edit it as you like.
Subject: Recall D-1059-2019 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-1059-2019 from Mylan. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1059-2019 (February 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1059-2019 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.