> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Mylan Recalls 2 Lots of Levoleucovorin Injection
- URL: https://www.fdaweb.com/mylan-recalls-2-lots-of-levoleucovorin-injection/
- Published: 2019-03-19T12:00:00.000Z
- Updated: 2026-09-15T01:13:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143639

Mylan has recalled two lots of levoleucovorin injection, 250 mg/25 mL due to the presence of particulate matter that has been identified as copper salts. The particles were discovered during 12-month stability testing, a [recall notice](https://www.fda.gov/Safety/Recalls/ucm633784.htm?ref=fdaweb.com) says. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan.

The product is indicated for rescue after high-dose methotrexate therapy in osteosarcoma; diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and inadvertent overdose of folic acid antagonists; and combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.