VIVITROL — Class II drug recall D-1556-2014
Terminated recall by Alkermes, Inc., reported 2014-09-03, distributed nationwide. Customer complaints for failure to deliver the dose.
| Recall number | D-1556-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alkermes, Inc., Waltham, MA, United States |
| Recall initiated | 2014-03-04 |
| Classified | 2014-08-22 |
| Reported by FDA | 2014-09-03 |
| Terminated | 2014-12-22 |
| Distributed | Nationwide (US) |
| Quantity | 4,364 vials |
| Reason classes | device malfunction |
| NDC | 65757-0300, 65757-0300-01, 65757-0301, 65757-0301-01, 65757-0302-02, 65757-0303-02, 65757-0304-03, 65757-0305-03 |
| Lot numbers | 2013-021, 412-3732AA |
| Expiration dates | 2016-07 |
Product
VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451.
Reason for recall
Customer complaints for failure to deliver the dose.
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-1556-2014. 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.