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D-0358-2025Class II

Somerset Therapeutics Private Limited

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Somerset Therapeutics Private Limited
Product type
Drug
Status
Ongoing
Report date
2025-04-16
Distribution
U.S. Nationwide
Firm state
N/A
Product quantity
240 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

Product description

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

Code / lot info

A240482D, exp. date 08/2026

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →