Haloperidol Decanoate Injection — Class III drug recall D-0818-2016
Terminated recall by Fresenius Kabi USA, LLC, reported 2016-04-20, distributed nationwide. Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specificatio
| Recall number | D-0818-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2016-04-07 |
| Classified | 2016-04-11 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2016-11-07 |
| Distributed | Nationwide (US) |
| Quantity | 48,210 units |
| Reason classes | specification failure |
| NDC | 63323-0469, 63323-0469-01, 63323-0469-05, 63323-0471, 63323-0471-01, 63323-0471-05 |
| Lot numbers | 6111080 |
| Expiration dates | 2017-01 |
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 for recall
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity 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-0818-2016. 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.