HALOPERIDOL DECANOATE INJECTION — Class III drug recall D-0247-2015
Terminated recall by Fresenius Kabi USA LLC, reported 2014-11-19, distributed nationwide. Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate
| Recall number | D-0247-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA LLC, Melrose Park, IL, United States |
| Recall initiated | 2014-04-14 |
| Classified | 2014-11-13 |
| Reported by FDA | 2014-11-19 |
| Terminated | 2016-03-08 |
| Distributed | Nationwide (US) |
| Quantity | 216,517 vials |
| Reason classes | specification failure |
| NDC | 63323-0469, 63323-0469-01, 63323-0469-05, 63323-0471, 63323-0471-01, 63323-0471-05 |
| Lot numbers | 02/15, 05/14, 07/14, 08/14, 12/14, 6105149, 6105696, 6105836, 6106516, 6106837 |
Product
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
Reason for recall
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
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-0247-2015. 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.