Medications & Supplements/Prescription Drugs

BluePoint Haloperidol Decanoate Injection Recalled for Sterility Concerns

Agency Publication Date: April 18, 2025

Summary

Amerisource Health Services LLC is recalling 16,442 vials of BluePoint Laboratories Haloperidol Decanoate Injection (50mg/mL and 100mg/mL) because bacterial contamination was detected in the manufacturing environment's testing units. This issue means there is a lack of assurance that the medication is sterile. Patients who use this medication should contact their healthcare provider or pharmacist.

Risk

Using an injectable medication that is not sterile can lead to serious, potentially life-threatening infections at the site of injection or within the bloodstream. No injuries or infections have been reported to date for these specific lots.

What You Should Do

This recall affects Haloperidol Decanoate Injection sold under the BluePoint Laboratories brand in 1 mL single-dose vials, including both 50mg/mL and 100mg/mL strengths.
Identify recalled products by checking the NDC and lot numbers on the carton or vial: NDC 68001-580-41 (Lot A240467B), NDC 68001-581-41 (Lot A240482A), or NDC 68001-581-48 (Lot A240482B). Affected expiration dates are July 31, 2026, and August 31, 2026.
If you have health concerns, contact your healthcare provider or pharmacist.
Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Haloperidol Decanoate Injection (50mg/mL), 1 mL Single-Dose Vialby BluePoint Laboratories

Variants: 50mg/mL, 1 mL Single-Dose Vial

Model:

D-0367-2025

Lot Numbers:

A240467B (Exp 07/31/2026)

NDC:

68001-580-41

Manufactured by Somerset Therapeutics Limited

Product: Haloperidol Decanoate Injection (100mg/mL), 1 x 1 mL Single-Dose Vialby BluePoint Laboratories

Variants: 100mg/mL, 1 x 1 mL Single-Dose Vial

Model:

D-0368-2025

Lot Numbers:

A240482A (Exp 08/31/2026)

NDC:

68001-581-41

Manufactured by Somerset Therapeutics Limited

Product: Haloperidol Decanoate Injection (100mg/mL), 5 x 1 mL Single-Dose Vialsby BluePoint Laboratories

Variants: 100mg/mL, 5 x 1 mL Single-Dose Vials

Model:

D-0369-2025

Lot Numbers:

A240482B (Exp 08/31/2026)

NDC:

68001-581-48

Manufactured by Somerset Therapeutics Limited

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96636

Status: Active

Manufacturer: Amerisource Health Services LLC

Sold By: BluePoint Laboratories

Manufactured In: India, United States

Units Affected: 3 products (2,110 vials; 14,189 vials; 143 1x5 vials)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Haloperidol Decanoate Injection sold under the BluePoint Laboratories brand in 1 mL single-dose vials, including both 50mg/mL and 100mg/mL strengths.

Identify recalled products by checking the NDC and lot numbers on the carton or vial: NDC 68001-580-41 (Lot A240467B), NDC 68001-581-41 (Lot A240482A), or NDC 68001-581-48 (Lot A240482B). Affected expiration dates are July 31, 2026, and August 31, 2026.

If you have health concerns, contact your healthcare provider or pharmacist.

Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Haloperidol Decanoate Injection (50mg/mL), 1 mL Single-Dose Vialby BluePoint Laboratories

Variants: 50mg/mL, 1 mL Single-Dose Vial

Model:

D-0367-2025

Lot Numbers:

A240467B (Exp 07/31/2026)

NDC:

68001-580-41

Manufactured by Somerset Therapeutics Limited

Product: Haloperidol Decanoate Injection (100mg/mL), 1 x 1 mL Single-Dose Vialby BluePoint Laboratories

Variants: 100mg/mL, 1 x 1 mL Single-Dose Vial

Model:

D-0368-2025

Lot Numbers:

A240482A (Exp 08/31/2026)

NDC:

68001-581-41

Manufactured by Somerset Therapeutics Limited

Product: Haloperidol Decanoate Injection (100mg/mL), 5 x 1 mL Single-Dose Vialsby BluePoint Laboratories

Variants: 100mg/mL, 5 x 1 mL Single-Dose Vials

Model:

D-0369-2025

Lot Numbers:

A240482B (Exp 08/31/2026)

NDC:

68001-581-48

Manufactured by Somerset Therapeutics Limited