Medications & Supplements/Prescription Drugs

Somerset and BluePoint Methocarbamol and Haloperidol Injections Recalled

Agency Publication Date: April 14, 2025

Summary

Somerset Therapeutics is recalling Methocarbamol Injection USP and Haloperidol Decanoate Injection because they may not be sterile. A total of 536,233 vials are affected by this recall. The company initiated the recall after discovering bacterial contamination in a manufacturing test designed to ensure the production environment is sterile. These are prescription-only injectable medications typically used in clinical settings for muscle relaxation or psychiatric treatment.

Risk

Injecting a product that is not sterile poses a significant health risk as it can introduce bacteria directly into the body. This could lead to serious systemic infections, abscesses, or life-threatening illnesses.

What You Should Do

This recall affects Methocarbamol Injection USP (1,000 mg/10 mL) and Haloperidol Decanoate Injection (50 mg/mL and 100 mg/mL) sold under the Somerset Therapeutics and BluePoint Laboratories brands.
Identify recalled products by checking the lot numbers and expiration dates on the vial or carton labels. Affected codes include NDC numbers 70069-101-25, 70069-101-05, 70069-381-01, 70069-381-10, 68001-580-41, 68001-581-41, 68001-581-48, and 70069-383-10. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product immediately.
Contact Somerset Therapeutics or your pharmaceutical distributor to arrange for the return of any remaining units.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Methocarbamol Injection USP (1,000 mg/10 mL)by Somerset Therapeutics

Variants: 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only

Lot Numbers:

A240304 (exp. date 05/2026)

A240305 (exp. date 05/2026)

A240320 (exp. date 05/2026)

A240322 (exp. date 05/2026)

A240334 (exp. date 05/2026)

A240335 (exp. date 05/2026)

A240340 (exp. date 05/2026)

A240342 (exp. date 06/2026)

A240347 (exp. date 06/2026)

A240385 (exp. date 06/2026)

A240391 (exp. date 06/2026)

A240326 (exp. date 05/2026)

NDC:

70069-101-25

70069-101-05

Quantity: 506,080 vials

Product: Haloperidol Decanoate Injection (50mg/mL)by Somerset Therapeutics

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

Lot Numbers:

A240467A (exp. date 07/2026)

A240467C (exp. date 07/2026)

NDC:

70069-381-01

70069-381-10

Quantity: 997 vials

Product: Haloperidol Decanoate Injection (50mg/mL) BluePoint labelby BluePoint Laboratories

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

Lot Numbers:

A240467B (exp. date 07/2026)

NDC:

68001-580-41

Quantity: 4956 vials

Product: Haloperidol Decanoate Injection (100mg/mL) BluePoint labelby BluePoint Laboratories

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

Lot Numbers:

A240482A (exp. date 08/2026)

A240482B (exp. date 08/2026)

NDC:

68001-581-41

68001-581-48

Quantity: 23,960 vials

Product: Haloperidol Decanoate Injection (100mg/mL) Somerset labelby Somerset Therapeutics

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

Lot Numbers:

A240482D (exp. date 08/2026)

NDC:

70069-383-10

Quantity: 240 vials

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96569

Status: Active

Manufacturer: Somerset Therapeutics Private Limited

Sold By: Wholesalers; Hospitals; Clinics

Manufactured In: India

Units Affected: 5 products (506,080 vials; 997 vials; 4956 vials; 23,960 vials; 240 vials)

Distributed To: Nationwide

Agency Last Updated: April 16, 2025

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 Methocarbamol Injection USP (1,000 mg/10 mL) and Haloperidol Decanoate Injection (50 mg/mL and 100 mg/mL) sold under the Somerset Therapeutics and BluePoint Laboratories brands.

Identify recalled products by checking the lot numbers and expiration dates on the vial or carton labels. Affected codes include NDC numbers 70069-101-25, 70069-101-05, 70069-381-01, 70069-381-10, 68001-580-41, 68001-581-41, 68001-581-48, and 70069-383-10. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product immediately.

Contact Somerset Therapeutics or your pharmaceutical distributor to arrange for the return of any remaining units.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Affected Products

Product: Methocarbamol Injection USP (1,000 mg/10 mL)by Somerset Therapeutics

Variants: 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only

Lot Numbers:

A240304 (exp. date 05/2026)

A240305 (exp. date 05/2026)

A240320 (exp. date 05/2026)

A240322 (exp. date 05/2026)

A240334 (exp. date 05/2026)

A240335 (exp. date 05/2026)

A240340 (exp. date 05/2026)

A240342 (exp. date 06/2026)

A240347 (exp. date 06/2026)

A240385 (exp. date 06/2026)

A240391 (exp. date 06/2026)

A240326 (exp. date 05/2026)

NDC:

70069-101-25

70069-101-05

Quantity: 506,080 vials

Product: Haloperidol Decanoate Injection (50mg/mL)by Somerset Therapeutics

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

Lot Numbers:

A240467A (exp. date 07/2026)

A240467C (exp. date 07/2026)

NDC:

70069-381-01

70069-381-10

Quantity: 997 vials

Product: Haloperidol Decanoate Injection (50mg/mL) BluePoint labelby BluePoint Laboratories

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

Lot Numbers:

A240467B (exp. date 07/2026)

NDC:

68001-580-41

Quantity: 4956 vials

Product: Haloperidol Decanoate Injection (100mg/mL) BluePoint labelby BluePoint Laboratories

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

Lot Numbers:

A240482A (exp. date 08/2026)

A240482B (exp. date 08/2026)

NDC:

68001-581-41

68001-581-48

Quantity: 23,960 vials

Product: Haloperidol Decanoate Injection (100mg/mL) Somerset labelby Somerset Therapeutics

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

Lot Numbers:

A240482D (exp. date 08/2026)

NDC:

70069-383-10

Quantity: 240 vials

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96569

Status: Active

Manufacturer: Somerset Therapeutics Private Limited

Sold By: Wholesalers; Hospitals; Clinics

Manufactured In: India

Units Affected: 5 products (506,080 vials; 997 vials; 4956 vials; 23,960 vials; 240 vials)

Distributed To: Nationwide

Agency Last Updated: April 16, 2025