RecallRadar

FDA Drug recall D-0506-2024

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 7006…

On 2024-05-29 the FDA classified a Class II recall of 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 7006… by Somerset Therapeutics, citing presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0506-2024
ClassificationClass II
Statusongoing
Initiated2024-04-24
Published2024-05-29
Last updated2026-09-13 11:52 UTC
CompanySomerset Therapeutics
DistributionUS

Product

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.

Reason

Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).

Identifiers

ndc70069-030-05
ndc70069-030-03
ndc70069-031-01
ndc70069-031-05
ndc70069-381-01
ndc70069-381-10
ndc70069-382-01
ndc70069-382-05
ndc70069-383-05
ndc70069-383-10
ndc70069-383-01
ndc70069-384-01
ndc70069-384-05
code_infoLot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0506-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.