Drug for aiding reproduction in cattle is recalled

Vetoquinol has recalled 6 lots of its porcine pituitary-derived follicle stimulating hormone injection (Folltropin) kits for use in cattle. The recall was initiated because particulate matter was found in the sterile diluent vial during routine examination of samples for the affected lots.^1,2

Each porcine pituitary-derived follicle stimulating hormone injection kit contains a single 20mL vial of lyophilized powder and one 20 mL vial of sterile bacteriostatic saline diluent. These kits are labeled with a lot number on the outside of the carton, and each vial of powder and sterile diluent are labeled with a separate lot number.^1,2

The affected kit lots are as follows^1,2:

1. 510578 kit lot with diluent lot 840915: Expiration date is May 31, 2026. Distribution dates are August 30-October 23, 2023.
2. 510589 kit lot with diluent lot 844585: Expiration date is May 31, 2026. Distribution dates are October 23-November 6, 2023.
3. 510580 kit lot with diluent lot 844583: Expiration date is May 31, 2026. Distribution dates are November 6, 2024-June 18, 2024.

1. 510581 kit lot with diluent lot 934975: Expiration date is January 31, 2027. Distribution dates are June 18,-December 13, 2024.
2. 510582 kit lot with diluent lot 934973. Expiration date is January 31, 2027. Distribution dates are December 13, 2024-June 9, 2025.
3. 717059 kit lot with diluent lot 934976: Expiration date is January 31, 2027. Distribution dates are June 9-October 28, 2025.

Porcine pituitary-derived follicle stimulating hormone injection is a highly purified extract that is lyophilized to maintain potency. The prescription drug is used to for the induction of superovulation in reproductively mature beef and dairy heifers and cows, according to Vetoquinol.^1,2

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, according to Vetoquinol. Possible clinical signs of an adverse event include pain, swelling and/or wounds at the injection site as well as decreased activity level, fever and/or labored breathing.^1,2

If any other concerning signs are observed in an animal that may have been administered the recalled product, a veterinarian should be contacted as soon as possible. No adverse event reports received for the listed batches, as of November 26, 2025.^1,2

Furthermore, Vetoquinol has not identified any issues with the product’s powder vial. Porcine pituitary-derived follicle stimulating hormone injection is also sold as a dual pack that is not impacted by the recall because it contains no diluent vials, according to Vetoquinol.^1,2

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.^1,2

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 am and 5 pm 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.

References

1. Vetoquinol USA, Inc. recalls six lots of Folltropin injectable kits for cattle due to presence of particulate matter in sterile diluent vial. News release. FDA. December 2, 2025. Accessed December 4, 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vetoquinol-usa-inc-recalls-six-lots-folltropin-injectable-kits-cattle-due-presence-particulate?utm_medium=email&utm_source=govdelivery
2. Company announcement— Vetoquinol USA, Inc. recalls six lots of Folltropin injectable kits for cattle due to presence of particulate matter in sterile diluent vial. News release. November 28, 2025. Accessed December 4, 2025. https://www.vetoquinolusa.com/news/press-release-folltropin-recall