Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Haloperidol Decanoate Injection 100mg/mL Recalled by Somerset Therapeutics Private Limited Due to Lack of Assurance of Sterility: Media fill with...
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 Private Limited directly.
Affected Products
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)
Quantity: 23,960 vials
Why Was This Recalled?
Lack of Assurance of Sterility: Media fill with bacterial contamination
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Somerset Therapeutics Private Limited
Somerset Therapeutics Private Limited has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report