Haloperidol Decanoate Injection
FDA Recall NDC 70069-030
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Haloperidol Decanoate (NDC 70069-030). A significant event, classified as Class II, was initiated on Mar 21, 2025 by Somerset Therapeutics, Llc. The reported reason for this action was: "Lack of Assurance of Sterility: Media fill with bacterial contamination"
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
Class II Ongoing
Lack of Assurance of Sterility: Media fill with bacterial contamination
Mar 21, 2025
Apr 16, 2025
240 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, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10
Batch or Lot Expiration Information
Lot# A240482D, exp. date 08/2026
Affected Packages Involved in this Recall
70069-030-05Product
70069-030-03Product
70069-031-01Product
70069-031-05Product
70069-381-01Product
70069-381-10Product
70069-382-01Product
70069-382-05Product
70069-383-05Product
70069-383-10Product
70069-383-01Product
70069-384-01Product
70069-384-05Product
Class II Ongoing
Lack of Assurance of Sterility: Media fill with bacterial contamination
Mar 21, 2025
Apr 16, 2025
997 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 for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)
Batch or Lot Expiration Information
Lot# NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026
Affected Packages Involved in this Recall
70069-030-05Product
70069-030-03Product
70069-031-01Product
70069-031-05Product
70069-381-01Product
70069-381-10Product
70069-382-01Product
70069-382-05Product
70069-383-05Product
70069-383-10Product
70069-383-01Product
70069-384-01Product
70069-384-05Product
Class II Ongoing
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Apr 24, 2024
May 29, 2024
5,578 units
Recall Profile & Regulatory Data
Event ID
94452
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SOMERSET THERAPEUTICS LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
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.
Batch or Lot Expiration Information
Lot# : a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
Affected Packages Involved in this Recall
70069-030-05Product
70069-030-03Product
70069-031-01Product
70069-031-05Product
70069-381-01Product
70069-381-10Product
70069-382-01Product
70069-382-05Product
70069-383-05Product
70069-383-10Product
70069-383-01Product
70069-384-01Product
70069-384-05Product
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.
