Haloperidol Decanoate Injection 100mg/mL — Class II drug recall D-0357-2025
Ongoing recall by Somerset Therapeutics Private Limited, reported 2025-04-16, distributed nationwide. Lack of Assurance of Sterility: Media fill with bacterial contamination
| Recall number | D-0357-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Somerset Therapeutics Private Limited, Bengaluru, N/A, India |
| Recall initiated | 2025-03-21 |
| Classified | 2025-04-08 |
| Reported by FDA | 2025-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 23,960 vials |
| Reason classes | microbial contamination, sterility |
| NDC | 68001-0578, 68001-0578-48, 68001-0578-59, 68001-0579, 68001-0579-48, 68001-0579-59, 68001-0580, 68001-0580-41, 68001-0581, 68001-0581-41, 68001-0581-48, 68001-0581-82, 68001-0582, 68001-0582-41 |
| Expiration dates | 2026-08 |
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)
Reason for recall
Lack of Assurance of Sterility: Media fill with bacterial contamination
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0357-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.