Elevated risk U.S. Food and Drug Administration

Dexased™ and Dexmedvet™ Dexmedetomidine Hydrochloride Injection 0.5 mg/mL recall: Presence of particulate matter

Recall published 1+ years ago

Presence of particulate matter

Dexased™ and Dexmedvet™ Pet food & treats — recalled pet food & treatsDexased™ and Dexmedvet™ Pet food & treats — recalled pet food & treats (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Sterility or particulate concern

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

What the notice says: Administration of an injectable product that contains particulate matter may result in serious adverse events.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
April 23, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Dexased™ and Dexmedvet™
Product type
Pet food & treats

Products covered by this recall

Dexmedetomidine Hydrochloride Injection 0.5 mg/mL

What the company announced

East Brunswick, NJ, April 23, 2025 - CRONUS PHARMA LLC, on behalf of Cronus Pharma Specialties, Hyderabad, India is issuing a voluntary recall involving one batch comprising two distinct lots: Dexased™ (Aspen) and Dexmedvet™ (Cronus Pharma LLC). Both products contain Dexmedetomidine Hydrochloride Injection 0.5 mg/mL, which is a prescription product in the United States used as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. This product is also indicated for use as a preanesthetic to general anesthesia in dogs and cats.

The recall is being conducted as a precautionary measure due to the presence of visible particulate matter (described as crystal-like particles, white floating matter, or precipitates) observed in the solution.

Crystal-like particles/White stuff floating/ Precipitate was observed during visual inspection of control samples for the following batches:

Dexased™: Dexmedetomidine Hydrochloride Injection 0.5mg/ml (Aspen), NDC No: 46066-088-13, Batch No: C24041AV1, Mfg. Date: Nov 2024, Exp. Date: Oct 2026. Distribution Dates: December 2024 to 04-April-2025

DexmedVet™: Dexmedetomidine Hydrochloride Injection 0.5mg/ml (Cronus Pharma LLC), NDC No: 69043-038-10, Batch No: C24041AV2, Mfg. Date: Nov 2024, Exp. Date: Oct 2026. Distribution Dates: March 2025 to 04-April-2025

A photo of the vial of each lot number that is part of the recall can be found at the end of this press release. The lot number (LOT) and expiry date (EXP) are located on the bottom right portion of the bottle label.

Administration of an injectable product that contains particulate matter may result in serious adverse events. Potential complications include inflammation, granuloma, fibrosis, and blockage of blood vessels in the heart, lungs or brain which can cause stroke or life-threatening blood clot events, including death. The overall risk depends on factors such as the route of injection, the composition of the particulate matter, and patient comorbidities.

Some possible signs and symptoms of an adverse event include pain, weakness, swelling, paralysis, fever, labored or fast breathing, vomiting, decreased activity level, vocalization, or loss of consciousness. If you observe any of these or any other concerning signs in an animal that may have been administered this product, please contact a veterinarian as soon as possible.

Dexmedetomidine Hydrochloride Injection 0.5 mg/mL is indicated for use as a sedative and analgesic in dogs and cats.

Customers who have received Dexased™ (Aspen ) & DexmedVet™ (Cronus Pharma LLC) from the lots ( C24041AV1 and C24041AV2 ) being recalled, should stop using the products and refer to your recall letter for product return instructions. Cronus Pharma LLC is working with its distributor partners to ensure that unused product is no longer in distribution or with customers. We are notifying our distributors and customers directly and are arranging for the return of the recalled product.

Consumers with technical questions regarding this recall should call 1-844-227-6687, Fax: 732-647-1272 and email to [email protected] (Monday through Friday 9 a.m. – 5 p.m. CDT). Customers who need to arrange return of product should contact their point of purchase for details.

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 made with the knowledge of the Food and Drug Administration.

The health and well-being of animals is the foremost priority at Cronus Pharma LLC. We place the utmost emphasis on product quality at every step in the manufacturing and supply chain process.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • C24041AV1
  • C24041AV2

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • Oct 2026

Package size

Match the net weight or the piece count on the front of the pack.

  • 0.5 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Dexased™ and Dexmedvet™ — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Report any infection or reaction you think the product caused to FDA MedWatch.
  3. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  4. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Cronus Pharma LLC — Consumers: 1-844-227-6687, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Dexased™ and Dexmedvet™ pet food & treats recalled?

Presence of particulate matter Administration of an injectable product that contains particulate matter may result in serious adverse events.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code C24041AV1, C24041AV2; best-by date Oct 2026. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

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