VIVITROL — Class II drug recall D-819-2013
Terminated recall by Alkermes, Inc., reported 2013-07-31, distributed nationwide. Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing duri
| Recall number | D-819-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alkermes, Inc., Waltham, MA, United States |
| Recall initiated | 2012-11-06 |
| Classified | 2013-07-24 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2013-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 3,325 vials |
| Reason classes | sterility, specification failure |
| 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 | 08/13, 10/13, 2011-003, 402-3683AA |
Product
VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451,
Reason for recall
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
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-819-2013. 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.