Adequan recall pulls four injectable lots over glass fibers

Bottom line

American Regent Animal Health has issued a nationwide, consumer-level recall of four lots of Adequan injectable products after glass fibers were found during testing of retained samples. The recall covers two lots of Adequan Canine Injection for dogs, lot numbers 3369 and 25011, and two lots of Adequan i.m. Injection for horses, lot numbers 24416 and 25265P. FDA posted the company announcement on August 3, 2026, after American Regent dated the recall notice July 31, 2026. The affected products were distributed in the U.S. to veterinarians, distributors, wholesalers, and online pharmacies between May 22, 2024, and January 22, 2026. American Regent said no adverse events had been reported at the time of the announcement. (fda.gov)

Why it matters: Adequan is a familiar prescription product in canine and equine joint care, so practices may need to review inventory, treatment records, and any product dispensed through hospital channels or home-delivery partners. FDA says particulate contamination in an intramuscular injectable can lead to local irritation, swelling, inflammation, injection-site pain, infection, or abscesses. The recall also matters operationally because it reaches the consumer level, meaning veterinary teams may need to proactively alert pet parents and horse clients, stop use immediately, and arrange returns or disposal of unused stock. (fda.gov)

What to watch: Watch for follow-up communication from American Regent on replacement supply, return logistics, and whether FDA later classifies or updates the recall. (fda.gov)

Key facts

Company
American Regent Animal Health
Recall type
Nationwide, consumer-level recall
Products
Adequan Canine Injection and Adequan i.m. Injection
Affected lots
Canine: 3369, 25011; horse: 24416, 25265P
Reason
Visible glass fiber material in retained samples
FDA posting date
2026-08-03
Recall notice date
2026-07-31
Distribution
U.S. veterinarians, distributors, wholesalers, and online pharmacies
Reported adverse events
None reported at the time of the announcement

American Regent Animal Health is recalling four lots of Adequan injections used in dogs and horses after testing found visible glass fiber material in retained samples, pulling the products back to the consumer level nationwide. The recall applies to Adequan Canine Injection lots 3369 and 25011, and Adequan i.m. Injection lots 24416 and 25265P. FDA published the company’s announcement on August 3, 2026, following American Regent’s July 31 notice. (fda.gov)

The products involved are well-established prescription therapies in veterinary practice. Adequan Canine is indicated for non-infectious degenerative or traumatic joint dysfunction in dogs, while Adequan i.m. is used for noninfectious degenerative or traumatic joint dysfunction and associated lameness in horses. FDA records show Adequan Canine has been marketed under NADA 141-038 since July 1, 1997, underscoring how embedded the brand is in companion animal medicine. (fda.gov)

According to the recall notice, the affected lots were distributed nationwide to veterinarians, distributors, wholesalers, and online pharmacies on four separate dates: May 22, 2024, and April 14, 2025, for the canine product, and May 8, 2025, and January 22, 2026, for the equine product. The recalled lots carry expiration dates ranging from October 31, 2026, to December 31, 2027, which means some vials could still be sitting in clinic inventory, ambulatory vehicles, pharmacy channels, or pet parent medicine cabinets. FDA says anyone with the affected lots should stop using them, and veterinary hospitals and clinics should return unused product to the manufacturer or discard it. (fda.gov)

The stated risk is tied to particulate contamination in an intramuscular injectable. American Regent said administration of a product containing glass fibers may cause local irritation, swelling, inflammation, injection-site pain, infection, or abscesses. At the time of the announcement, the company said it had not received reports of adverse events related to the recalled lots. For adverse-event reporting, the company directs veterinarians and clients to its pharmacovigilance channel, and FDA also accepts animal drug adverse event reports. (fda.gov)

Public industry reaction has so far centered less on debate and more on amplification. AVMA Recall Watch and trade outlets including dvm360 and Veterinary Practice News circulated the recall details, emphasizing the lot numbers and the need to stop use immediately. That muted reaction is notable in itself: this appears to be a straightforward quality recall rather than a signal of a newly emerging clinical safety issue with the active ingredient, polysulfated glycosaminoglycan. (fda.gov)

Why it matters: For veterinary professionals, the practical impact is likely to be larger than the number of recalled lots suggests. Adequan is a commonly recognized option in osteoarthritis and lameness management, and the recall spans both small animal and equine channels. Practices may need to reconcile stock across multiple storage sites, identify patients who received product from the affected lots, answer questions from pet parents about risk, and document any post-injection complications that could be tied to particulate contamination. Because some recalled product moved through online pharmacies as well as clinics, communication may need to extend beyond in-house dispensing records. (fda.gov)

There’s also a workflow issue. If a clinic relies on Adequan protocols for ongoing canine osteoarthritis management or equine lameness cases, even a targeted recall can force short-term treatment-plan adjustments, especially for patients on scheduled injection series. The recall notice does not announce a broader shortage, but it does create a near-term need for inventory checks, substitution planning where appropriate, and clear client messaging about which lot numbers are affected and what symptoms warrant follow-up. That analysis is an inference based on the product’s role in practice and the consumer-level scope of the recall. (fda.gov)

What to watch: The next signals to watch are whether FDA assigns a formal recall classification, whether American Regent issues additional instructions on replacement or credit, and whether any adverse-event reports emerge as clinics and pet parents review past use of the affected lots. (fda.gov)

How this developed

  1. Affected product was distributed in the U.S.

  2. Affected canine product was distributed in the U.S.

  3. Affected equine product was distributed in the U.S.

  4. Affected equine product was distributed in the U.S.

  5. American Regent dated the recall notice.

  6. FDA posted the company announcement.

Common questions

  • Which Adequan lots are recalled?
    Adequan Canine Injection lots 3369 and 25011, and Adequan i.m. Injection lots 24416 and 25265P.
  • Why are these products being recalled?
    Testing found visible glass fiber material in retained samples.
  • What should a pet parent or clinic do with affected product?
    Stop using the affected lots. FDA says veterinary hospitals and clinics should return unused product to the manufacturer or discard it.
  • Were any adverse events reported?
    American Regent said no adverse events had been reported at the time of the announcement.

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