FDA Drug recall D-0356-2025
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Man…
- FDA Drug
- Class II
- ongoing
- Published 2025-04-16
On 2025-04-16 the FDA classified a Class II recall of Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Man… by Somerset Therapeutics Private, citing lack of Assurance of Sterility: Media fill with bacterial contamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0356-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-21 |
| Published | 2025-04-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Somerset Therapeutics Private |
| Distribution | US |
Product
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41
Reason
Lack of Assurance of Sterility: Media fill with bacterial contamination
Identifiers
| ndc | 68001-579-59 |
|---|---|
| ndc | 68001-579-48 |
| ndc | 68001-580-41 |
| ndc | 68001-581-41 |
| ndc | 68001-581-48 |
| ndc | 68001-581-82 |
| ndc | 68001-578-59 |
| ndc | 68001-578-48 |
| ndc | 68001-582-41 |
| code_info | A240467B, exp. date 07/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0356-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.