FDA Recall D-0358-2025
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, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10
Reason for recall
Lack of Assurance of Sterility: Media fill with bacterial contamination
Recall record
- Recall number
D-0358-2025- 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.