FDAFDA · Food and drugs·Recall number D-0355-2025
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)
Published April 16, 2025 · Recall initiated: March 21, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Media fill with bacterial contamination
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Somerset Therapeutics Private Limited
- Distributor
- U.S. Nationwide
- UPC
- 0370069382011
- Lot
- NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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