The Recall Desk
HighFDA (Drugs)·D-0173-2025·Announced 2025-01-08

Ketamine injection syringes recalled due to missing tamper-evident seals

Hikma Injectables is recalling 1,800 ketamine injection syringes nationwide because tamper-evident seals are not attached to several syringes, compromising sterility assurance.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall of a sterile injectable product where the tamper-evident seal integrity is compromised, creating a risk of contamination. Although no illnesses or injuries have been reported, the loss of sterility assurance on an injectable product used in clinical settings presents a potential for serious harm and meets the criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Hikma Injectables USA Inc is recalling 1,800 ketamine 50 mg/mL pre-filled injection syringes distributed nationwide. This is a compounded drug intended for hospital and office use only. The recall affects two product lots: lot number 242560008D (use-by date January 15, 2025) and lot number 242970002D (use-by date February 25, 2025).

The tamper-evident seals on several syringes are not attached upon receipt of shipment. Tamper-evident seals are critical for maintaining the sterility assurance of injectable products. Without an intact seal, the sterility of the product cannot be assured, creating a risk of contamination.

Healthcare facilities and providers with the recalled syringes should discontinue use immediately. The syringes are 1 mL fills in 3 mL pre-filled syringes for IV or IM administration. Do not use the product. Contact Hikma Injectables USA Inc at 36 Stults Road, Dayton, NJ 08810 for return instructions or further information.

The recalled product

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
Manufacturer
Hikma Injectables USA Inc
Category
Drug — Injectable Medication
Hazard
  • tamper-seal-failure
  • sterility-assurance

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot number: 242560008D
  • Use by Date 01/15/2025
  • 242970002D
  • Use by Date 02/25/2025

Distribution

Distributed nationwide across the United States.

Related recalls

Same category