Fluphenazine Decanoate Injection — Class III drug recall D-0647-2017
Terminated recall by Fresenius Kabi USA, LLC, reported 2017-04-12, distributed nationwide. Subpotent Drug
| Recall number | D-0647-2017 |
|---|---|
| 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 | 2017-03-16 |
| Classified | 2017-04-05 |
| Reported by FDA | 2017-04-12 |
| Terminated | 2018-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 118,224 vials |
| Reason classes | potency |
| NDC | 63323-0272-05 |
| Lot numbers | 01/18, 03/18, 07/17, 08/17, 6111141, 6111222, 6112346, 6112725 |
Product
Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05
Reason for recall
Subpotent Drug
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-0647-2017. 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.