Recalls / Class II
Class IID-0358-2025
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
- Brand name
- Haloperidol Decanoate
- Generic name
- Haloperidol Decanoate
- Active ingredient
- Haloperidol Decanoate
- Route
- Intramuscular
- NDCs
- 70069-030, 70069-031, 70069-381, 70069-382, 70069-383, 70069-384
- FDA application
- ANDA209101
- Affected lot / code info
- A240482D, exp. date 08/2026
Why it was recalled
Lack of Assurance of Sterility: Media fill with bacterial contamination
Recalling firm
- Firm
- Somerset Therapeutics Private Limited
- Manufacturer
- Somerset Therapeutics, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 54/1 Budihal Village, N/A, Bengaluru, N/A N/A, India
Distribution
- Quantity
- 240 vials
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-03-21
- FDA classified
- 2025-04-08
- Posted by FDA
- 2025-04-16
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0358-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.