Recalls / Class II
Class IID-0368-2025
Product
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.
- 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
- A240482A, EXP 08/31/2026
Why it was recalled
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Recalling firm
- Firm
- Amerisource Health Services LLC
- Manufacturer
- BluePoint Laboratories
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 14,189 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-04-02
- FDA classified
- 2025-04-18
- Posted by FDA
- 2025-04-30
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0368-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.