Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)
Class I - DangerousWhat Should You Do?
- Check if you have this product: NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Somerset Therapeutics Private Limited
- Reason for Recall:
- Lack of Assurance of Sterility: Media fill with bacterial contamination
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)
Product Codes/Lot Numbers:
NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0355-2025
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