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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Vet
Pets & Animals/Pet Medications

Cronus Pharma Injectable Medications Recalled for Manufacturing Issues

Agency Publication Date: November 20, 2025
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Summary

Cronus Pharma is voluntarily recalling several batches of Florfeniject (florfenicol), AnaSed Equine Injection (xylazine), and Ketamine Hydrochloride Injection. The recall was initiated following an internal review of manufacturing control changes that are currently being evaluated by the FDA. While no adverse events or quality issues have been reported and all batches met specifications at the time of release, these products are being recalled as a precautionary measure. Consumers and veterinary professionals should contact the manufacturer or their supplier to arrange for the return of the affected products.

Risk

Manufacturing control changes implemented in these batches are under regulatory evaluation; while no injuries have been reported, the recall ensures that only products with fully validated manufacturing processes remain in use.

What You Should Do

  1. Identify if you have the affected products by checking the lot numbers and expiration dates on the vial labels for Florfeniject (Lots C24043AVI, C24045AVI, C24047AVI), AnaSed Equine (Lots C24048AVI, C24049AVI, C25042AVI, C25043AVI, C25044AVI), or Ketamine (Lot C25058AVI). See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled product immediately.
  3. Contact the manufacturer, Cronus Pharma, or your distributor to arrange for the return of any unused product or for proper disposal instructions.
  4. If you have animal health concerns regarding a patient or pet that received these medications, contact your veterinarian.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return or proper disposal.

Affected Products

Product: Florfeniject, (florfenicol) Injectable Solution (300 mg/ml)
Variants: 250mL, 500mL, Sterile Multiple-Dose Vial
Lot Numbers:
C24043AVI (Exp Date: October 2026)
C24045AVI (Exp Date: November 2026)
C24047AVI (Exp Date: November 2026)
NDC:
69043-044-25
69043-044-50

Injectable antibiotic for animals.

Product: AnaSed Equine Injection, (xylazine injection) (100 mg/ml)
Variants: 50mL, Sedative
Lot Numbers:
C24048AVI (Exp Date: November 2026)
C24049AVI (Exp Date: November 2026)
C25042AVI (Exp Date: March 2027)
C25043AVI (Exp Date: March 2027)
C25044AVI (Exp Date: April 2027)
NDC:
69043-043-05

For intravenous (IV) or intramuscular (IM) use in horses only.

Product: Ketamine, Hydrochloride Injection (100 mg/ml)
Variants: 10mL
Lot Numbers:
C25058AVI (Exp Date: May 2027)
NDC:
69043-063-01

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97867
Status: Active
Manufacturer: Cronus Pharma
Sold By: Veterinary distributors; Wholesalers
Manufactured In: United States, India
Distributed To: Nationwide
Agency Last Updated: December 8, 2025

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 ยท Raw API Response