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Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset...

FDA Recall #D-0356-2025 — Class II — March 21, 2025

Recall #D-0356-2025 Date: March 21, 2025 Classification: Class II Status: Ongoing

Product Description

Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41

Reason for Recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

Recalling Firm

Somerset Therapeutics Private Limited — Bengaluru, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

4956 vials

Distribution

U.S. Nationwide

Code Information

A240467B, exp. date 07/2026

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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