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Recall Enforment Report D-0368-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Amerisource Health Services LLC, originally initiated on 04-02-2025 for the product Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41. The product was recalled due to lack of assurance of sterility. bacterial contamination detected in some media fill units. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0368-202504-02-202504-30-2025Class II14,189 vialsHaloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.Lack of assurance of sterility. Bacterial contamination detected in some media fill unitsOngoing
D-0369-202504-02-202504-30-2025Class II143 1x5 vialsHaloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48.Lack of assurance of sterility. Bacterial contamination detected in some media fill unitsOngoing
D-0367-202504-02-202504-30-2025Class II2,110 vialsHaloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.Lack of assurance of sterility. Bacterial contamination detected in some media fill unitsOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
68001-578Haloperidol Decanoate Haloperidol DecanoateInjectionIntramuscularBluepoint LaboratoriesHuman Prescription Drug
68001-579Haloperidol Decanoate Haloperidol DecanoateInjectionIntramuscularBluepoint LaboratoriesHuman Prescription Drug
68001-580Haloperidol Decanoate Haloperidol DecanoateInjectionIntramuscularBluepoint LaboratoriesHuman Prescription Drug
68001-581Haloperidol Decanoate Haloperidol DecanoateInjectionIntramuscularBluepoint LaboratoriesHuman Prescription Drug
68001-582Haloperidol Decanoate Haloperidol DecanoateInjectionIntramuscularBluepoint LaboratoriesHuman Prescription Drug