FDA Drug recall D-0247-2015
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
- FDA Drug
- Class III
- terminated
- Published 2014-11-19
On 2014-11-19 the FDA classified a Class III recall of HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01 by Fresenius Kabi Usa, citing failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0247-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-04-14 |
| Published | 2014-11-19 |
| 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, Schaumburg, IL 60173 NDC 63323-469-01
Reason
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Identifiers
| ndc | 63323-469-01 |
|---|---|
| ndc | 63323-469-05 |
| ndc | 63323-471-01 |
| ndc | 63323-471-05 |
| code_info | Lot 6105149, Exp.05/14; 6105696, Exp. 07/14; 6105836, Exp. 08/14; Lot 6106516, Exp. 12/14; Lot 6106837, Exp. 02/15 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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All Fresenius Kabi Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0247-2015%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.