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Class II · ModerateRecall completed

ketamine inj 50 mg per 1 mL

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot number: 242560008D, Use by Date 01/15/2025; 242970002D, Use by Date 02/25/2025
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forHikma Injectables USA Inc
NDC63037-137-25
Show the full FDA record
Full product labelketamine 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
Recalling firmHikma Injectables USA Inc
DistributionNationwide in the USA
Quantity1,800 syringes
Recall initiated2024-12-19
Report date2025-01-08
Recall completed2025-11-12
Recall numberD-0173-2025
ClassificationClass II
FDA statusTerminated
Origin on fileDayton NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.