Recalls / Class II
Class IID-0357-2025
Product
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)
- Brand name
- Haloperidol Decanoate
- Generic name
- Haloperidol Decanoate
- Active ingredient
- Haloperidol Decanoate
- Route
- Intramuscular
- NDCs
- 68001-578, 68001-579, 68001-580, 68001-581, 68001-582
- FDA application
- ANDA209101
- Affected lot / code info
- NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, 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
- BluePoint Laboratories
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 54/1 Budihal Village, N/A, Bengaluru, N/A N/A, India
Distribution
- Quantity
- 23,960 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-0357-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.