Hikma Injectables USA recalls ketamine syringes with potential tamper-evident seal issues. The recall addresses lack of sterility assurance due to improper seal attachment during shipping. Affected products include specific lot numbers and use-by dates.
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Hikma Injectables USA is recalling ketamine injection syringes that may have improper tamper-evident seals. This could lead to contamination risks if the syringes are used without proper sterility assurance.
The tamper-evident seals on some syringes were not properly attached during shipping. This could allow contamination if the syringes are used without adequate sterility assurance, potentially leading to infections.
Healthcare professionals and hospitals using the recalled ketamine syringes for IV or IM injections are affected. Patients receiving injections from these syringes could be at risk if the seals are compromised.
Check for lot numbers 242560008D (use by 01/15/2025) or 242970002D (use by 02/25/2025) on the syringe packaging. The product is a compounded drug for hospital or office use only.
Look for lot numbers 242560008D or 242970002D on the syringe packaging.
The recall is due to lack of assurance of sterility because the tamper-evident seals on some syringes were not properly attached during shipping.
Check the lot number on the syringe packaging. If it matches 242560008D or 242970002D, contact Hikma Injectables USA for instructions.
The recall addresses potential contamination risks, but the remedy does not specify a risk of serious injury or death. This is considered a low-risk issue.
We’ve drafted a message you can send Hikma Injectables USA to request your refund or repair — edit it as you like.
Subject: Recall D-0173-2025 — Hikma Injectables USA Hikma Injectables USA Hello, I own a Hikma Injectables USA that is covered by recall D-0173-2025 from Hikma Injectables USA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.