Haloperidol Decanoate Injection — Class II drug recall D-0422-2015
Terminated recall by Mylan Institutional LLC, reported 2015-04-01, distributed nationwide. Lack of Assurance of Sterility; due to leaking vials
| Recall number | D-0422-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional LLC, Rockford, IL, United States |
| Recall initiated | 2015-02-18 |
| Classified | 2015-03-23 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2017-02-23 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, packaging |
| NDC | 67457-0409, 67457-0409-00, 67457-0409-13, 67457-0410, 67457-0410-00, 67457-0410-13 |
| Lot numbers | 7/16, 7602368, 7602369 |
Product
Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103
Reason for recall
Lack of Assurance of Sterility; due to leaking vials
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-0422-2015. 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.