American Regent, Inc. Animal Health Issues Nationwide Recall of two lots of Adequan® Canine and two lots of Adequan® i.m. due to visible glass fiber material in the product

SHIRLEY, N.Y., July 31, 2026 /PRNewswire/ — American Regent, Inc. Animal Health is conducting a nationwide recall of two lots (25011 and 3369) of Adequan® Canine Injection (for dogs), 100 mg/mL 5 mL multi-dose vials and two lots (24416 and 25265P)of Adequan® i.m. Injection (for horses), 500 mg/5 mL single-dose 5 mL vials to the consumer level. The products are being recalled due to the presence of glass fibers found during testing of internally retained samples.

Risk Statement: The administration of anintramuscularinjectable product containing particulate matter, such as glass fibers, may result in local irritation,swelling,inflammation,injection site pain,infection,or abscesses.To date, American Regent, Inc. has not received any reports of adverse events related tothe recalled lots.

BothAdequan Canineand Adequani.m.areclear, colorlessto slightlyyellow solutions.The products are for intramuscular injections and are to be used by or under the direction of a licensed veterinarian.

Adequan Canine is a prescription medication used in the treatment ofnon-infectious degenerative or traumatic joint dysfunctionin dogs.

Adequan i.m. is a prescription medication used in the treatment of noninfectious degenerative or traumatic joint dysfunction and associated lamenessin horses.

Adequan Canine Lot #’s 3369 and 25011 were distributed nationwide to online pharmacies, distributors/ wholesalers and veterinarians in the United States on 05/22/2024 and 04/14/2025 respectively and Adequan i.m. Lot #’s 24416 and 25265P were distributed nationwide to online pharmacies, distributors/ wholesalers and veterinarians in the United States on 05/08/2025 and 01/22/2026 respectively.

Product Description

NADA

Lot #

Distribution Date

Expiration Date

Adequan
Canine
Injection,
100 mg/1 mL

5 mL multi-dose vial

141-038

3369

05/22/2024

10/31/2026

Adequan
Canine
Injection,
100 mg/1 mL

5 mL multi-dose vial

141-038

25011

04/14/2025

12/31/2027

Adequan i.m.Injection,
500 mg/5 mL

5mL single-dose vial

140-901

24416

05/08/2025

11/30/2027

Adequani.m.Injection,
500 mg/5 mL

5mL single-dose vial

140-901

25265P

01/22/2026

03/31/2027

Any person or entity with the recalled product lots should not use the products.

Consumers: Stop using the recalled products lots. Contact your veterinarian if your pets have experienced any problems that may be related to using the recalled products.

Distributorsandretailers: Stopdistribution, return anyleftoverrecalledproduct to the manufacturer,or discard.

Veterinary hospitals, clinics, and otherconsignees: Return anyunused product to the manufacturer or discard.

CONTACT AMERICAN REGENT INC.
Consumers and veterinary professionals with questions regarding this recall can contact American Regent Inc. using the below information.

Area of Support

Contact Center

Contact Information

For detailed
return/replacement/credit
information

American Regent,
Inc. Customer
Service

Phone: 800-645-1706
(8:00AM-6:00PM EST, Monday –
Thursday, 8:00AM-4:00PM EST, Friday)
Email: [emailprotected]

To report adverse events

American Regent,
Inc.
Pharmacovigilance

Phone: 888-354-4857

(24 Hours/Day, 7 Days/Week)

Email:[emailprotected]

For product quality
complaints

American Regent,
Inc. Product
Quality
Complaints

Phone: 888-354-4855

(24 Hours/Day, 7 Days/Week)

Email:[emailprotected]

For medical questions

American Regent,
Inc. Medical
Information

Phone: 888-354-4857

(24 Hours/Day, 7 Days/Week)

Email:[emailprotected]

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 recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

American Regent, Inc. is committed to the safety of patients who rely on its products and is taking this precautionary action to protect public health.

SOURCE American Regent, Inc.

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