Pet Products Medium Severity Voluntary

American Regent Recalls Adequan Canine and Adequan I.M. Over Glass Fibers

Advertisement

American Regent, Inc. Animal Health is conducting a nationwide recall of two lots of Adequan Canine Injection for dogs and two lots of Adequan i.m. Injection for horses after glass fiber material was discovered in the product during internal testing. The recall covers prescription intramuscular joint medications distributed to online pharmacies, distributors, wholesalers and veterinarians across the United States.

What Products Are Being Recalled?

The recall includes Adequan Canine Injection, 100mg/mL, 5mL multi-dose vials, lots 3369 and 25011, and Adequan i.m. Injection, 500mg/5mL, 5mL vials, lots 24416 and 25265P. Adequan Canine lots were distributed on 05/22/2024 and 04/14/2025, with expiration dates of 10/31/2026 and 12/31/2027 respectively. Adequan i.m. lots were distributed on 05/08/2025 and 01/22/2026, with expiration dates of 11/30/2027 and 03/31/2027. Both products are clear, colorless to slightly yellow solutions intended for intramuscular use under a licensed veterinarian’s direction.

Why Was This Recall Issued?

The recall was triggered after glass fibers were found during testing of internally retained samples. According to the company, administering an intramuscular injectable product containing particulate matter such as glass fibers may cause local irritation, swelling, inflammation, injection site pain, infection or abscesses. American Regent stated it has not received any reports of adverse events related to the recalled lots to date.

Who Is Affected?

Adequan Canine is used to treat non-infectious degenerative or traumatic joint dysfunction in dogs, while Adequan i.m. is used to treat noninfectious degenerative or traumatic joint dysfunction and associated lameness in horses. Pet owners whose dogs or horses received these medications from veterinarians, online pharmacies, distributors or wholesalers within the affected distribution windows may be impacted. Veterinary hospitals and clinics that stock the recalled lots are also affected.

Advertisement

What Should You Do?

Consumers should immediately stop using the recalled product lots and contact their veterinarian if their pets have experienced any problems that may be related to using the recalled products. Distributors and retailers should stop distribution and return any leftover recalled product to the manufacturer or discard it. Veterinary hospitals, clinics and other consignees should return unused product to the manufacturer or discard it. For return, replacement or credit information, consumers and professionals can contact American Regent Customer Service at 800-645-1706 or cs@americanregent.com. To report adverse events, contact Pharmacovigilance at 888-354-4857 or animalhealth@americanregent.com. Adverse reactions or quality problems may also be reported to the FDA at 1-888-FDA-VETS or online through FDA’s Safety Reporting Portal.

Official Statement

American Regent, Inc. said it is committed to the safety of patients who rely on its products and is taking this precautionary action to protect public health. The company confirmed this recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Advertisement