DexmedVet and Pivetal DEXASED Sterile Injectables Recalled for Visible Particles

Agency Publication Date: May 12, 2025

Summary

Cronus Pharma is recalling several lots of DexmedVet (dexmedetomidine hydrochloride) and Pivetal DEXASED (dexmedetomidine hydrochloride) sterile injectable solutions used for veterinary sedation. The recall was initiated after a market complaint identified white sediment, crystals, or floating particles in the solution. Consumers should stop using the affected products immediately, as the presence of particulate matter in an injectable medication can cause serious harm to animals.

Risk

Injecting a solution containing visible particles or crystals can cause inflammation, blood vessel blockages, or life-threatening embolisms in the animal being treated.

What You Should Do

Identify the affected products by checking the lot numbers and NDC codes on the 10 mL vials or packaging. For DexmedVet, look for Lot # C24041AV2 (Exp Oct 2026) with NDC 69043-038-10. For Pivetal DEXASED, look for Lot # C24041AV1 (Exp Oct 2026) with NDC 46066-088-13.
If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer or supplier for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, or contact the manufacturer or supplier for further instructions

Option 2: Dispose of Product

How to: Throw the product away.

Affected Products

Product: DexmedVet, dexmedetomidine hydrochloride, 0.5 mg/mL (5 mg/10 mL), Sterile Injectable Solution (10 mL)by DexmedVet

Variants: 0.5 mg/mL (5 mg/10 mL), Sterile Injectable Solution

Lot Numbers:

C24041AV2 (Exp Oct 2026)

NDC:

69043-038-10

Manufactured for: Cronus Pharma LLC

Product: Pivetal, DEXASED, dexmedetomidine hydrochloride, 0.5 mg/mL (5 mg/10 mL), Sterile Injectable Solution (10 mL)by Pivetal / DEXASED

Variants: 0.5 mg/mL (5 mg/10 mL), Sterile Injectable Solution

Lot Numbers:

C24041AV1 (Exp Oct 2026)

NDC:

46066-088-13

Manufactured for: Aspen Veterinary Resources, LTD.

Product Images

Labeling, Dexased Injection

Labeling, DexmedVet

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96673

Status: Active

Manufacturer: Cronus Pharma

Sold By: veterinary clinics; distributors

Manufactured In: India

Distributed To: Nationwide

Agency Last Updated: June 17, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

Summary

What You Should Do

Identify the affected products by checking the lot numbers and NDC codes on the 10 mL vials or packaging. For DexmedVet, look for Lot # C24041AV2 (Exp Oct 2026) with NDC 69043-038-10. For Pivetal DEXASED, look for Lot # C24041AV1 (Exp Oct 2026) with NDC 46066-088-13.

If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer or supplier for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

Option 2: Dispose of Product

How to: Throw the product away.

Affected Products

Product: DexmedVet, dexmedetomidine hydrochloride, 0.5 mg/mL (5 mg/10 mL), Sterile Injectable Solution (10 mL)by DexmedVet

Variants: 0.5 mg/mL (5 mg/10 mL), Sterile Injectable Solution

Lot Numbers:

C24041AV2 (Exp Oct 2026)

NDC:

69043-038-10

Manufactured for: Cronus Pharma LLC

Product: Pivetal, DEXASED, dexmedetomidine hydrochloride, 0.5 mg/mL (5 mg/10 mL), Sterile Injectable Solution (10 mL)by Pivetal / DEXASED

Variants: 0.5 mg/mL (5 mg/10 mL), Sterile Injectable Solution

Lot Numbers:

C24041AV1 (Exp Oct 2026)

NDC:

46066-088-13

Manufactured for: Aspen Veterinary Resources, LTD.