CLASS II Drug recall · Reported 8 Jan 2025 · FDA Enforcement Report
ketamine inj 50 mg recalled by Hikma Injectables USA
Hikma Injectables USA is recalling ketamine inj 50 mg per, distributed nationwide in the US. The recall was initiated on 19 Dec 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0173-2025
- FDA event ID
- 95993
- Recalling firm
- Hikma Injectables USA, Dayton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Dec 2024
- FDA classified
- 2 Jan 2025
- Reported
- 8 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 19 Dec 2024 | Recall initiated by company | |
| 2 Jan 2025 | Classified by FDA | +14 days |
| 8 Jan 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Is ketamine inj 50 mg per recalled?
Yes. Hikma Injectables USA recalled ketamine inj 50 mg per on 19 Dec 2024. The recall is Class II and its status is Terminated. Recall number D-0173-2025.
Why was it recalled?
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Which lots are affected?
Lot number: 242560008D, Use by Date 01/15/2025; 242970002D, Use by Date 02/25/2025
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hikma Injectables USA
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | phenylephrine in 9% Sodium Chloride Inj, 1mg per (100 mcg/mL) recalled | Hikma Injectables USA | Sterility | Nationwide |
| Drug | CLASS I | Phenylephrine in 9% Sodium Chloride Injection Preservative recalled | Hikma Injectables USA | Labeling Errors | 5 states |
| Drug | CLASS III | Fentanyl 1000mcg/ (10mcg/mL) in 9% Sodium Chloride Injection recalled | Hikma Injectables USA | Packaging Defects | Nationwide |