Haloperidol Decanoate Injection — Class II drug recall D-0369-2025
Ongoing recall by Amerisource Health Services LLC, reported 2025-04-30, distributed nationwide. Lack of assurance of sterility. Bacterial contamination detected in some media fill units
| Recall number | D-0369-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerisource Health Services LLC, Columbus, OH, United States |
| Recall initiated | 2025-04-02 |
| Classified | 2025-04-18 |
| Reported by FDA | 2025-04-30 |
| Distributed | Nationwide (US) |
| Quantity | 143 |
| 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 | 2026-08-31 |
Product
Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48.
Reason for recall
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
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-0369-2025. 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.