Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Haloperidol Decanoate Injection Recalled by Amerisource Health Services LLC Due to Lack of assurance of sterility. Bacterial contamination detected...

Date: April 2, 2025
Company: Amerisource Health Services LLC
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Amerisource Health Services LLC directly.

Affected Products

Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.

Quantity: 2,110 vials

Why Was This Recalled?

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Amerisource Health Services LLC

Amerisource Health Services LLC has 43 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report