Vetoquinol USA, Inc. Recalls Six Lots of FOLLTROPIN Injectable Kits for Cattle Due to Presence of Particulate Matter in Sterile Diluent Vial

Summary

Company Announcement Date: November 26, 2025 FDA Publish Date: December 02, 2025 Product Type: Animal & Veterinary Reason for Announcement:

Recall Reason Description

Presence of particulate matter

Company Name: Vetoquinol USA Brand Name: Product Description:

Product Description

FOLLTROPIN Injectable Kits for Cattle

Company Announcement

November 26, 2025 – Vetoquinol USA, Inc., Fort Worth, TX, is recalling six lots of FOLLTROPIN® (porcine pituitary-derived follicle stimulating hormone for injection) Kits, due to the presence of particulate matter in the sterile diluent vial.

Particulates were observed during routine examination of retained samples of the sterile diluent vials for the following lots:

Risk Statement: The administration of an injectable product that contains particulate matter may result in injection site reaction or hypersensitivity reaction in response to the foreign material. Some possible clinical signs of an adverse event include pain and/or swelling/wounds at the injection site, as well as decreased activity level, fever, and/or labored breathing. If you observe any of these or any other concerning signs in an animal that may have been administered this product, please contact a veterinarian as soon as possible. To date, no adverse event reports have been received for the listed batches.

About Folltropin: Folltropin is a porcine pituitary-derived follicle stimulating hormone approved in the US for intramuscular injection for the induction of superovulation in beef and dairy heifers and cows. Folltropin is a prescription product in the U.S.

The Folltropin Kit consists of one 20 mL vial of Folltropin lyophilized FSH powder and one 20 mL vial of sterile bacteriostatic saline diluent. The Folltropin Kit is labeled with a lot number on the outside of the carton. The Folltropin powder and the sterile diluent are each labeled with a separate lot number on their respective vials.

The product was marketed by veterinary distributors nationwide in the U.S.

Vetoquinol USA, Inc. has not identified any issues with the Folltropin powder vial. Folltropin is also sold as a Dual Pack (contains two vials of Folltropin FSH powder) which is not impacted by the recall because it contains no diluent vials.

The particulate matter was discovered during routine annual inspection of retain samples of the sterile diluent vials.

Customers who have received FOLLTROPIN Kits from the batches impacted by this recall should stop using the product immediately and quarantine product subject to recall. Please contact Vetoquinol USA, Inc. for further instructions for returning or disposal of the recall product.

Consumers with questions regarding this company announcement should call Vetoquinol USA, Inc. at 1-800-267-5707 Monday through Friday between the hours of 8 a.m. and 5 p.m. Central Standard Time.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae

This company announcement is being made with the knowledge of the Food and Drug Administration.

Company Contact Information

Product Photos

• Content current as of:

  12/02/2025

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