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Drug FDA Class II Terminated Contamination / non-sterility

phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25

Hikma Injectables USA Inc Published Jan 8, 2025

Risk level

Class II

May 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 Assurance of Sterility · primary

Affected products (1)

phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25
Lot codes: number
Code info: Lot number: 243120003D, Use by Date: 03/11/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Dec 19, 2024
  2. Published
    Jan 8, 2025
  3. Terminated
    Nov 12, 2025
Recall number
D-0174-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

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.