Haloperidol Decanoate Injection
FDA Recall NDC 68001-581
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Haloperidol Decanoate (NDC 68001-581). A significant event, classified as Class II, was initiated on Apr 02, 2025 by Bluepoint Laboratories. The reported reason for this action was: "Lack of assurance of sterility. Bacterial contamination detected in some media fill units"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
April 2025 Class II Recall: Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Recall Number
Class II Ongoing
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Apr 02, 2025
Apr 30, 2025
143 1x5 vials
Recall Profile & Regulatory Data
Event ID
96636
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Haloperidol 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.
Batch or Lot Expiration Information
Lot# A240482B, EXP 08/31/2026
Affected Packages Involved in this Recall
68001-579-59Product
68001-579-48Product
68001-580-41Product
68001-581-41Product
68001-581-48Product
68001-581-82Product
68001-578-59Product
68001-578-48Product
68001-582-41Product
April 2025 Class II Recall: Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Recall Number
Class II Ongoing
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Apr 02, 2025
Apr 30, 2025
14,189 vials
Recall Profile & Regulatory Data
Event ID
96636
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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.
Batch or Lot Expiration Information
Lot# A240482A, EXP 08/31/2026
Affected Packages Involved in this Recall
68001-579-59Product
68001-579-48Product
68001-580-41Product
68001-581-41Product
68001-581-48Product
68001-581-82Product
68001-578-59Product
68001-578-48Product
68001-582-41Product
April 2025 Class II Recall: Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Recall Number
Class II Ongoing
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Apr 02, 2025
Apr 30, 2025
2,110 vials
Recall Profile & Regulatory Data
Event ID
96636
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Haloperidol 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.
Batch or Lot Expiration Information
Lot# A240467B, EXP 07/31/2026
Affected Packages Involved in this Recall
68001-579-59Product
68001-579-48Product
68001-580-41Product
68001-581-41Product
68001-581-48Product
68001-581-82Product
68001-578-59Product
68001-578-48Product
68001-582-41Product
Class II Ongoing
Lack of Assurance of Sterility: Media fill with bacterial contamination
Mar 21, 2025
Apr 16, 2025
23,960 vials
Recall Profile & Regulatory Data
Event ID
96569
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Somerset Therapeutics Private Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
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)
Batch or Lot Expiration Information
Lot# NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026
Affected Packages Involved in this Recall
68001-579-59Product
68001-579-48Product
68001-580-41Product
68001-581-41Product
68001-581-48Product
68001-581-82Product
68001-578-59Product
68001-578-48Product
68001-582-41Product
Class II Ongoing
Lack of Assurance of Sterility: Media fill with bacterial contamination
Mar 21, 2025
Apr 16, 2025
4956 vials
Recall Profile & Regulatory Data
Event ID
96569
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Somerset Therapeutics Private Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41
Batch or Lot Expiration Information
Lot# A240467B, exp. date 07/2026
Affected Packages Involved in this Recall
68001-579-59Product
68001-579-48Product
68001-580-41Product
68001-581-41Product
68001-581-48Product
68001-581-82Product
68001-578-59Product
68001-578-48Product
68001-582-41Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
