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Drug FDA Class II Ongoing Contamination / non-sterility

Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)

Somerset Therapeutics Private Limited Published Apr 16, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

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 Somerset Therapeutics Private Limited or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

Hazards

Bacterial contamination · primary

Affected products (1)

Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)

HALOPERIDOL DECANOATE · 997 vials

NDC: 70069-030, 70069-031, 70069-381, 70069-382, 70069-383, 70069-384, 70069-030-05, 70069-030-03, 70069-031-01, 70069-031-05, 70069-381-01, 70069-381-10, 70069-382-01, 70069-382-05, 70069-383-05, 70069-383-10, 70069-383-01, 70069-384-01, 70069-384-05
Code info: NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Mar 21, 2025
  2. Published
    Apr 16, 2025
Recall number
D-0355-2025
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.