Why it was recalled
Lack of Assurance of Sterility: Media fill with bacterial contamination
Product description
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)
Lot numbers, UPCs & expiration codes
NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026
Where it was sold
U.S. Nationwide
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-0357-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 21, 2025
- FDA report date
- Apr 16, 2025
- Quantity
- 23,960 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Somerset Therapeutics Private Limited
Original FDA data
Every field from FDA enforcement report D-0357-2025, exactly as published.
Show all FDA fields
- City
- Bengaluru
- Status
- Ongoing
- Country
- India
- Event ID
- 96569
- Address
- 54/1 Budihal Village
- Code information
- NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026
- Report date
- Apr 16, 2025
- Product type
- Drugs
- Recall number
- D-0357-2025
- Classification
- Class II
- Recalling firm
- Somerset Therapeutics Private Limited
- Product quantity
- 23,960 vials
- Reason for recall
- Lack of Assurance of Sterility: Media fill with bacterial contamination
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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)
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Mar 21, 2025
- Initial firm notification
- Letter
- Center classification date
- Apr 8, 2025