FDA Recall D-0369-2025

Amerisource Health Services LLC · Columbus, OH

Class II Ongoing 407 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, 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.

Lot / code: A240482B, EXP 08/31/2026

Quantity: 143 1x5 vials

Reason for recall

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Recall record

Recall number: D-0369-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-04-02
Classified by FDA Center: 2025-04-18
FDA published: 2025-04-30
Recalling firm: Amerisource Health Services LLC
Firm location: Columbus, OH

Drug identification

Brand name(s): HALOPERIDOL DECANOATE
Generic name(s): HALOPERIDOL DECANOATE
Manufacturer(s): BluePoint Laboratories
NDC(s): 68001-578, 68001-579, 68001-580, 68001-581, 68001-582
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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