American Regent, Inc. Animal Health has issued a nationwide recall of four pharmaceutical lots due to visible glass fiber material contamination, according to an FDA alert issued July 31, 2026. The recall affects two lots of Adequan® Canine Injection (100 mg/mL, 5 mL multi-dose vials) and two lots of Adequan® i.m. Injection for horses (500 mg/mL), representing a significant quality and safety concern for veterinary practitioners.
Key takeaways
- Four product lots affected: Canine lots 25011 and 3369; equine lots 24416 and 25265P
- Contaminant identified as visible glass fiber material in multi-dose vials
- Recall is nationwide; veterinarians and horse owners advised to check inventory immediately
- No adverse events reported at time of FDA announcement, but risk of injection site injury remains
Recall Details and Affected Products
The U.S. Food and Drug Administration confirmed the recall affects Adequan® Canine Injection lots 25011 and 3369, and Adequan® i.m. (intramuscular) Injection lots 24416 and 25265P. American Regent, Inc. Animal Health, headquartered in Shirley, New York, manufactures both products, which are widely used in veterinary practice for joint and musculoskeletal conditions in companion animals and equines.
The visible glass fiber material represents a physical contamination hazard with potential to cause injection site trauma, infection, or foreign body reactions at the point of administration. Multi-dose vials present additional risk due to repeated needle punctures during use. Veterinarians should quarantine all vials from the affected lots and verify product lot numbers before administering any remaining inventory.
Safety Risk Assessment and Clinical Implications
While American Regent reported no adverse events associated with the contamination at the time of the FDA recall announcement, the presence of glass fiber material in injectable pharmaceuticals poses direct patient risk. Injection of glass particles can cause localized inflammation, abscess formation, or needle deflection during administration. In equine populations, such complications may lead to lameness or prolonged recovery.
The recall demonstrates the critical importance of visual inspection protocols in pharmaceutical manufacturing and quality control. American Regent’s parent company, Luitpold Pharmaceuticals, operates under FDA oversight; this recall triggers investigation into manufacturing and containment procedures at the facility responsible for these batches. Regulatory quality and safety standards require manufacturers to implement corrective and preventive action (CAPA) plans to prevent recurrence.
Veterinary Practice Response and Inventory Management
Veterinary clinics and equine practitioners must immediately check inventory against the recalled lot numbers. Affected vials should be removed from use and stored separately pending return to the distributor or manufacturer. The FDA Safety Alerts system recommends contacting American Regent at 1-888-REGENT-1 for return authorizations and replacement stock arrangements.
Practitioners should document which patients may have received product from the recalled lots and maintain communication with owners regarding the contamination risk. Although no adverse events were reported as of the recall date, delayed presentations of injection site complications are possible, particularly in equine patients where subtle gait changes may be overlooked initially. Clinicians should remain alert for atypical inflammatory responses or persistent lameness in animals treated during the affected manufacturing periods.
American Regent, Inc. Animal Health conducts nationwide recall of Adequan® Canine lots 25011 and 3369, and Adequan® i.m. lots 24416 and 25265P due to visible glass fiber contamination in multi-dose vials.
— U.S. Food and Drug Administration Safety Alert (July 31, 2026)
What this means
Frequently asked questions
How can I tell if my pet received product from a recalled lot?
Check your veterinary medical records for the treatment date and injection details. Contact your veterinarian’s office with the date of treatment; they can cross-reference the Adequan® lot number on their records against the recalled lot numbers: Canine lots 25011 and 3369, or equine lots 24416 and 25265P. Your veterinarian’s pharmacy records will show the specific lot number dispensed.
What should I do if I have unused recalled vials?
Do not use the product. Store vials separately in a cool, dry location away from treatment areas. Contact American Regent at 1-888-REGENT-1 to request a return authorization number and replacement product. Follow the FDA’s return instructions for proper handling and documentation.
What symptoms should I watch for in my animal after receiving Adequan®?
Monitor injection sites for excessive swelling, heat, discharge, or abscess formation. In dogs, observe for lameness or reluctance to use the treated limb. In horses, watch for subtle gait abnormalities, decreased athletic performance, or localized swelling at the injection site. Contact your veterinarian if any of these signs develop, as they may indicate a complication from glass particle injection.
American Regent’s recall reflects broader quality assurance challenges in pharmaceutical manufacturing. The company’s response timeline and transparency will be monitored by the FDA and veterinary profession as this incident progresses. Replacement lot distribution is expected to resume within two weeks, according to industry sources familiar with similar recall logistics. Veterinary practitioners are advised to verify lot numbers on all new Adequan® shipments before placing them in active inventory.
Source: FDA Safety Alert: American Regent, Inc. Animal Health Issues Nationwide Recall of Adequan® Products
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