FDA Drug recall D-0173-2025
ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road,…
- FDA Drug
- Class II
- terminated
- Published 2025-01-08
On 2025-01-08 the FDA classified a Class II recall of ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road,… by Hikma Injectables Usa, citing lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0173-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-12-19 |
| Published | 2025-01-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hikma Injectables Usa |
| Distribution | US |
Product
ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25
Reason
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Identifiers
| code_info | Lot number: 242560008D, Use by Date 01/15/2025; 242970002D, Use by Date 02/25/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0173-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.