Prescription sedative and analgesic is voluntarily recalled

A voluntary recall of a prescription sedative and analgesic for companion animals has been issued by Cronus Pharma. One lot each for 2 products containing dexmedetomidine hydrochloride injection 0.5 mg/mL (Dexased, Aspen; and Dexmedvet, Cronus Pharma) are recalled as a precautionary measure because of the presence of visible particulate matter.

“The health and well-being of animals is the foremost priority at Cronus Pharma. We place the utmost emphasis on product quality at every step in the manufacturing and supply chain process,” the company noted in a news release.¹

The recalled dexmedetomidine hydrochloride injection products are used for feline and canine patients to help facilitate clinical examinations and procedures as well as minor surgical and dental procedures. Additionally, dexmedetomidine hydrochloride injection is indicated for use in dogs and cats as a preanesthetic to general anesthesia, according to the FDA.

Photos courtesy of FDA

Particulate matter was observed as crystal-like particles or “white stuff floating” during visual inspection of control samples for Dexased and Dexmedvet, according to the FDA. Identifying information for the recalled lots are as follows¹:

• Dexased: Dexmedetomidine Hydrochloride Injection 0.5mg/ml (Aspen), NDC No: 46066-088-13, Batch No: C24041AV1. Manufacturing date: November 2024. Expiration date: October 2026. Distribution dates: December 2024 to April 4, 2025.
• DexmedVet: Dexmedetomidine hydrochloride Injection 0.5mg/ml (Cronus Pharma LLC), NDC No: 69043-038-10, Batch No: C24041AV2. Manufacturing date: November 2024. Expiration date: October 2026. Distribution dates: March 2025 to April 4, 2025.

Pet owners who have received recalled lots of the affected dexmedetomidine hydrochloride injection products should be advised to stop using them. 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.¹

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, according to the FDA. If these or any other concerning signs are observed in an animal that may have been administered this recalled product, a veterinarian should be contacted as soon as possible. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA at 1-888-FDA-VETS or online at www.FDA.gov/reportanimalae.

Cronus Pharma—a division of Cronus Pharma Specialties in Hyderabad, India—is working with distribution partners to help ensure that unused product is no longer being distributed or with customers. Cronus Pharma is also notifying its distributors and customers directly and are arranging for the return of the recalled product.¹

Pet owners in possession of the affected products with recalled lots should refer to the recall notification with instructions for returns or contact their point of purchase for details. Pet owners with technical questions regarding the recall should call 1-844-227-6687 and send an email to pv@cronuspharmausa.com.¹

Reference

Cronus Pharma LLC initiating voluntary recall for (Dexased-Aspen and Dexmedvet\-Cronus Pharma LLC) of dexmedetomidine hydrochloride Injection 0.5 mg/mL for veterinary use due to presence of particulate matter. News release. April 23, 2025. Accessed April 29, 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cronus-pharma-llc-initiating-voluntary-recall-dexasedtm-aspen-and-dexmedvettm-cronus-pharma-llc