Adequan Canine for dogs: evidence, safety, and 2026 recall

Bottom line: Adequan Canine (polysulfated glycosaminoglycan injection) is FDA approved for intramuscular use in dogs to control signs associated with non-infectious degenerative and/or traumatic arthritis of canine synovial joints. American Regent recalled lots 3369 and 25011 nationwide because glass fibers were found in retained samples. Affected lots should not be used.

CURRENT RECALL — checked August 19, 2026. American Regent announced a nationwide consumer-level recall of Adequan Canine 5 mL multi-dose vial lots 3369 and 25011 after glass fibers were found in retained samples. Lot 3369 expires October 31, 2026; lot 25011 expires December 31, 2027. The manufacturer says particulate matter such as glass fibers may result in local irritation, swelling, inflammation, injection-site pain, infection, or abscess. Affected lots should not be used. Contact a veterinarian if a dog may have experienced a problem related to a recalled lot.

Educational information only. This record does not diagnose joint disease, choose a treatment, reproduce a dose, or replace a veterinarian’s assessment of a dog’s history, examination, other medicines, and monitoring needs.

1. Treatment and scope

This record covers Adequan Canine, whose active ingredient is polysulfated glycosaminoglycan, for the FDA-defined dog use involving clinical signs associated with degenerative joint disease and/or traumatic arthritis. The current official label describes a prescription animal drug solution for intramuscular use in dogs.

The scope does not silently extend to cats, horses, humans, another condition, another formulation, a compounded preparation, or an extra-label decision. A veterinarian must determine whether the dog’s signs and diagnosis fit the decision being discussed.

2. Regulatory status

FDA approved — defined scope: FDA’s original approval record is NADA 141-038, with an approval date of July 15, 1997. The official label and DailyMed listing support the product identity, dog route, prescription restriction, and labeled use. The status, label, and recall notice were checked August 19, 2026.

FDA approval is not a universal suitability, safety, superiority, or outcome guarantee. It does not silently extend to another species, another route, another product, or a claim beyond the labeled scope.

3. Evidence stage

FDA-reviewed target-species evidence: The current label describes a laboratory distribution study and a randomized, masked, saline-controlled field trial in 51 dogs with radiographically confirmed traumatic and/or degenerative joint disease. Twenty-four dogs received Adequan Canine. After four weeks, treated dogs showed statistically significant improvement over placebo-treated dogs in range of motion and total orthopedic score.

The clinical sample was small, the treatment period was short, and the study does not establish long-term outcomes or comparative superiority over other treatments.

4. Benefits, limits, and safety

The supported clinical question is control of signs associated with non-infectious degenerative and/or traumatic arthritis of canine synovial joints. The label does not establish joint repair, cure, long-term comparative superiority, or a guaranteed response for an individual dog.

The label says not to use Adequan Canine in dogs with hypersensitivity to PSGAG or known or suspected bleeding disorders. Safe use has not been evaluated in breeding, pregnant, or lactating dogs, and the label advises caution in dogs with renal or hepatic impairment.

Possible reactions reported in the clinical field trial included transient injection-site pain, transient diarrhea, and abnormal bleeding. Post-approval reports include vomiting, anorexia, depression or lethargy, diarrhea, and, in some cases, death. Because these reports are voluntary, they cannot reliably establish frequency or causation. The lot-specific recall described above concerns glass fibers and must be checked before use. Do not start, stop, combine, or substitute medicines based on this record.

5. Cost data status

No treatment-price range is published yet. This page currently explains cost components only.

It will be updated when the Index has enough source-dated, location-labeled observations to show a clearly limited sample without implying a national or typical price.

Until then, request an itemized estimate that separates the examination, diagnostics, drug or administration, monitoring, repeat visits, and other care. A single product, dose, or visit price is not necessarily the complete cost of treatment.

6. Insurance status and variables

This page does not determine whether a claim is covered, and no treatment-specific policy comparison has been completed.

Coverage depends on the policy form, state, version or effective date, waiting period, pre-existing-condition terms, applicable treatment category, deductible, reimbursement percentage, limits, exclusions, and claim facts. Use the actual policy and a written insurer response for a specific claim.

7. Legitimate access

The official label states that federal law restricts Adequan Canine to use by or on the order of a licensed veterinarian and identifies intramuscular use in dogs. Legitimate access begins with a veterinary evaluation, prescription decision, and administration plan. This page is not a pharmacy and does not provide dosing instructions.

8. Established alternatives

Depending on diagnosis and patient factors, a veterinarian may discuss other medicines, rehabilitation, activity or home-environment changes, weight management, supportive care, referral, surgical evaluation, or a different plan. The relevant comparison includes indication, expected outcome, safety, monitoring, cost, coverage, and access. This record does not rank the options.

9. Appropriate next step

If a veterinarian has raised Adequan Canine, ask:

• What diagnosis and treatment goal are we addressing?
• What does the planned course include, and what would trigger reassessment?
• What other medicines or health conditions affect the safety discussion?
• What are the complete expected costs, including administration and repeat visits?
• Which policy provisions and pre-existing-condition rules may matter?
• Which established alternatives belong in the same comparison?

Sources and claim verification

1. FDA FOI Summary, NADA 141-038 — supports the July 15, 1997 approval record, product identity, dog scope, and FDA-reviewed indication context; checked August 18, 2026.
2. DailyMed official Adequan Canine label — supports the current label listing, prescription restriction, product identity, and intramuscular use in dogs; label updated October 7, 2024 and checked August 18, 2026.
3. Adequan Canine official printer-friendly label — supports label warnings, precautions, administration context, and other current label details; checked August 18, 2026.
4. FDA-posted American Regent recall announcement — supports the nationwide recall of lots 3369 and 25011, the glass-fiber reason, risk statement, expiration dates, and instruction not to use affected lots; company announcement July 31, 2026, FDA publication August 3, 2026, checked August 19, 2026.

Change log

• August 19, 2026: Added the nationwide recall for lots 3369 and 25011; corrected the labeled indication; added the 51-dog field-study result; and added label contraindications, precautions, adverse reactions, and post-approval information.