Vetoquinol FOLLTROPIN Injectable Kits Recalled: Particulate Matter in Diluent
Date: December 2, 2025 Recall type: Voluntary Company: Vetoquinol USA, Inc. Product: FOLLTROPIN Injectable Kits for Cattle Species: Cattle Reason: Presence of particulate matter in sterile diluent vial Distribution: Nationwide (veterinary distributors)
What Was Recalled
FOLLTROPIN (porcine pituitary-derived follicle stimulating hormone for injection) Kits consisting of one 20 mL vial of lyophilized FSH powder and one 20 mL vial of sterile bacteriostatic saline diluent.
Affected lot numbers: Kit lots 510578, 510579, 510580, 510581, 717059, 510582 (corresponding diluent lots 840915, 844585, 844583, 934975, 934976, 934973) with expiration dates of 5/31/2026 and 1/31/2027
Why
Particulate matter was observed during routine examination of retained samples of the sterile diluent vials. The issue affects only the diluent vials; no problems were identified with the Folltropin powder.
Risk
Administration of injectable products containing particulate matter may result in injection site reaction or hypersensitivity reaction. Possible clinical signs include pain and/or swelling/wounds at injection site, decreased activity level, fever, and/or labored breathing. No adverse event reports have been received for the listed batches.
What To Do
- Check inventory for FOLLTROPIN Kits with matching lot numbers on carton labels
- Stop use immediately and quarantine recalled product
- Contact Vetoquinol USA at 1-800-267-5707 Monday-Friday 8AM-5PM CST for return/disposal instructions
- Report adverse events to FDA via FDA Form 1932a or 1-888-FDA-VETS
Source
Vetoquinol USA, Inc. Recalls Six Lots of FOLLTROPIN Injectable Kits for Cattle Due to Presence of Particulate Matter in Sterile Diluent Vial — FDA, December 2, 2025