Why it was recalled
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Product description
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.
Lot numbers, UPCs & expiration codes
A240482A, EXP 08/31/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0368-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 2, 2025
- FDA report date
- Apr 30, 2025
- Quantity
- 14,189 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services LLC
Original FDA data
Every field from FDA enforcement report D-0368-2025, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 96636
- Address
- 2550 John Glenn Ave Ste A
- Code information
- A240482A, EXP 08/31/2026
- Postal code
- 43217-1188
- Report date
- Apr 30, 2025
- Product type
- Drugs
- Recall number
- D-0368-2025
- Classification
- Class II
- Recalling firm
- Amerisource Health Services LLC
- Product quantity
- 14,189 vials
- Reason for recall
- Lack of assurance of sterility. Bacterial contamination detected in some media fill units
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 2, 2025
- Initial firm notification
- Letter
- Center classification date
- Apr 18, 2025