Drug FDA Class II Terminated Contamination / non-sterility
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
Hikma Injectables USA Inc Published Jan 8, 2025
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 55/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Hikma Injectables USA Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Hazards
Lack of Sterility Assurance - Missing Tamper-Evident Seal · primary
Affected products (1)
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
1,800 syringes
Lot codes: number
Code info: Lot number: 242560008D, Use by Date 01/15/2025; 242970002D, Use by Date 02/25/2025
Affected areas
Nationwide
Timeline
- InitiatedDec 19, 2024
- PublishedJan 8, 2025
- TerminatedNov 12, 2025
- Recall number
- D-0173-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.