Cronus Pharma initiating Voluntary Recall for Florfenicol Injection (250 mL, 500 mL), Xylazine Hydrochloride (50 mL), and Ketamine Hydrochloride (10 mL) Due to Precautionary Measure
East Brunswick, NJ, October 24, 2025 – CRONUS PHARMA LLC, on behalf of Cronus Pharma Specialities, Hyderabad, India is issuing a voluntary recall involving:
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- ANADA 200-760 Florfeniject, Florfenicol Injectable Solution, 300 mg/mL
- NADA 140-442 AnaSed Equine Injectable Solution, Xylazine Injection, 100 mg/ml
- ANADA 200-029 Ketamine Hydrochloride Injectable Solution, 100 mg/ml
This recall is being undertaken following internal review of certain manufacturing control changes implemented in recent batches, which are still currently under FDA evaluation. There have been no reports of adverse events or product quality issues, and all released lots met approved finished product specifications at the time of release.
This action is being taken out of a precautionary measure to ensure continued compliance with our high standards and ongoing regulatory expectations.
Use of these products is not likely to cause any potential health hazards.
| S.No. | Product Name and Strength | NDC No. | Lot Number | Mfg. Date | Exp. Date |
| 1. | Florfenicol injection 300 mg/ml, 250 ml | 69043-044-25 | C24043AV1 | November 2024 |
October 2026 |
| 2. | Florfenicol Injection 300 mg/ml, 500 ml | 69043-044-50 | C24045AV1 | December 2024 |
November 2025 |
| 3. | Florfenicol Injection 300 mg/ml, 500 ml | 69043-044-50 | C24047AV1 | December 2024 |
November 2025 |
| 4. | Xylazine hydrochloride injection, USP 100mg/ml 50 ml | 69043-044-05 | C24048AV1 | December 2024 |
November 2025 |
| 5. | Xylazine hydrochloride injection, USP 100mg/ml 50 ml | 69043-044-05 | C24049AV1 | December 2024 |
November 2025 |
| 6. | Xylazine hydrochloride injection, USP 100mg/ml 50 ml | 69043-044-05 | C25042AV1 | April 2025 |
March 2027 |
| 7. | Xylazine hydrochloride injection, USP 100mg/ml 50 ml | 69043-044-05 | C25043AV1 | April 2025 |
March 2027 |
| 8. | Xylazine hydrochloride injection, USP 100mg/ml 50 ml | 69043-043-05 | C25044AV1 | May 2025 |
April 2027 |
| 9. | Ketamine Hydrocholride Injection, 100 mg/ml 10 ml | 69043-063-01 | C25058AV1 | June 2025 |
May 2027 |
The above products were shipped between January-2025 to September-2025
Action to be taken by the Distributor
- Immediately examine your inventory, stop distributing these Lot numbers and quarantine any product bearing the above Lot numbers.
- Please carry out a physical count and record the data on the enclosed response form.
- Ask the veterinary practice or retail unit to whom the product was distributed to stop distribution or dispensing these lot numbers and return any leftover stock on their shelf.
- Upon receipt of your confirmation, Cronus Pharma LLC shall provide a return authorization to return any inventory with the above Lot numbers.
- Please also share with Cronus Pharma LLC the full list of veterinary practices and retail units affected by these lot numbers.
If you have further distributed this recalled product to other, please notify the concerned wholesalers at once of this recall. Customers who need to arrange return of product should contact their point of purchase for details. If you have any questions regarding the return of this recall product, please contact your Sales Representative or Jignesh Shah (jshah@cronuspharmausa.com).
This recall is being made with the knowledge of the Food and Drug Administration.
We regret any inconvenience and your cooperation to this notice is much appreciated. If you have Customer Service-related questions, please contact (contact@cronuspharmausa.com). For medical or drug safety related questions, please contact (pv@cronuspharmausa.com). Thank you for your support and understanding.
