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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Somerset Haloperidol decanoate Injection Recalled for Water Contamination

Agency Publication Date: May 21, 2024
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Summary

Somerset Therapeutics LLC is recalling 5,578 units of Somerset Therapeutics Haloperidol decanoate Injection 50mg/mL. This oil-based medication may contain trace amounts of water for injection, which is considered a foreign substance for this specific formulation. The recall affects 1 mL single-dose vials and 10-vial cartons distributed nationwide within the United States. Healthcare facilities should immediately stop using the affected lots to ensure patient safety.

Risk

The presence of water in an oil-based injectable drug can compromise the stability and quality of the medication. This defect may lead to reduced drug effectiveness or unexpected adverse reactions when administered to patients.

What You Should Do

  1. This recall affects Somerset Therapeutics Haloperidol decanoate Injection 50mg/mL sold in 1 mL single-dose vials (NDC 70069-381-01) and cartons containing 10 vials (NDC 70069-381-10). Affected lot numbers are A230412A and A230412B, both with an expiration date of 07/2025.
  2. Stop using the recalled product. Contact Somerset Therapeutics LLC or your pharmaceutical distributor to arrange for the return of any unused vials in your inventory.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Haloperidol decanoate Injection 50mg/mL
Variants: 50mg/mL, 1 mL Single-Dose Vial, 10-Vial Carton
Lot Numbers:
A230412A (Exp 07/2025)
A230412B (Exp 07/2025)
NDC:
70069-381-01
70069-381-10

Recall Number: D-0506-2024; Rx only; Manufactured for Somerset Therapeutics, LLC.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94452
Status: Active
Manufacturer: SOMERSET THERAPEUTICS LLC
Sold By: Hospitals; Surgical Centers; Pharmaceutical Wholesalers
Manufactured In: India
Units Affected: 5,578 units
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 ยท 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.