Drug & Device Safety Atlas

FDA drug recalls · openFDA

Is HALOPERIDOL DECANOATE recalled?

The FDA has recorded 8 recalls of HALOPERIDOL DECANOATE (2024–2025) , recalled under brand like HALOPERIDOL DECANOATE. 8 still ongoing.

0
Class I (most serious)
8
Class II
0
Class III
8
ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of HALOPERIDOL DECANOATE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

Lack of Assurance of Sterility: Media fill with bacterial contamination 4
Lack of assurance of sterility. Bacterial contamination detected in some media fill units 3
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI). 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Class II ongoing
Somerset Therapeutics Private Limited 2025-03-21 lots: A240467B, exp. date 07/2026
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Class II ongoing
Amerisource Health Services LLC 2025-04-02 lots: A240482A, EXP 08/31/2026
Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Class II ongoing
Amerisource Health Services LLC 2025-04-02 lots: A240482B, EXP 08/31/2026
Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limite Class II ongoing
Amerisource Health Services LLC 2025-04-02 lots: A240467B, EXP 07/31/2026
Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Class II ongoing
Somerset Therapeutics Private Limited 2025-03-21 lots: A240482D, exp. date 08/2026
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, So Class II ongoing
Somerset Therapeutics Private Limited 2025-03-21 lots: NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Class II ongoing
Somerset Therapeutics Private Limited 2025-03-21 lots: NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-D Class II ongoing
SOMERSET THERAPEUTICS LLC 2024-04-24 lots: Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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