ketamine inj 50 mg per 1 mL recall
FDA recall D-0173-2025 · initiated Dec 19, 2024
Hikma Injectables USA Inc recalled ketamine inj 50 mg per 1 mL in Dec 2024 — an FDA Class II recall (D-0173-2025) because Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1,800 syringes
Details
- 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
- Recalling company
- Hikma Injectables USA Inc
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Dec 19, 2024
- FDA report date
- Jan 8, 2025
Frequently asked
- Was ketamine inj 50 mg per 1 mL recalled?
- Hikma Injectables USA Inc recalled ketamine inj 50 mg per 1 mL in Dec 2024 — an FDA Class II recall (D-0173-2025) because Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was ketamine inj 50 mg per 1 mL recalled?
- Per the FDA enforcement record, the reason for recall D-0173-2025 was: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
- Is a recalled ketamine inj 50 mg per 1 mL dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of ketamine inj 50 mg per 1 mL are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot number: 242560008D, Use by Date 01/15/2025; 242970002D, Use by Date 02/25/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0173-2025.