FDA Drug recall D-0818-2016
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only
- FDA Drug
- Class III
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class III recall of Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only by Fresenius Kabi Usa, citing failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0818-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-04-07 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
Reason
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Identifiers
| ndc | 63323-469-01 |
|---|---|
| ndc | 63323-469-05 |
| ndc | 63323-471-01 |
| ndc | 63323-471-05 |
| code_info | Lot #: 6111080, Exp. 01/2017 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0818-2016%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.