FDA Recall D-0355-2025

Somerset Therapeutics Private Limited · Bengaluru, N/A

Class II Ongoing 419 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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)

Lot / code: NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026

Quantity: 997 vials

Reason for recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

Recall record

Recall number: D-0355-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide
Recall initiated: 2025-03-21
Classified by FDA Center: 2025-04-08
FDA published: 2025-04-16
Recalling firm: Somerset Therapeutics Private Limited
Firm location: Bengaluru, N/A, India

Drug identification

Brand name(s): HALOPERIDOL DECANOATE
Generic name(s): HALOPERIDOL DECANOATE
Manufacturer(s): Somerset Therapeutics, LLC
NDC(s): 70069-030, 70069-031, 70069-381, 70069-382, 70069-383, 70069-384
Route(s): INTRAMUSCULAR

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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