Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Haloperidol decanoate Injection 50mg/mL Recalled by SOMERSET THERAPEUTICS LLC Due to Presence of Foreign Substance: This oil based product...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SOMERSET THERAPEUTICS LLC directly.
Affected Products
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.
Quantity: 5,578 units
Why Was This Recalled?
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SOMERSET THERAPEUTICS LLC
SOMERSET THERAPEUTICS LLC has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report