Drug FDA Class II Ongoing Contamination / non-sterility

Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10

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, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10

HALOPERIDOL DECANOATE · 240 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: A240482D, exp. date 08/2026

Affected areas

Nationwide

Timeline

Initiated

Mar 21, 2025
Published

Apr 16, 2025

Recall number: D-0358-2025
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.