Vivitrol — Class II drug recall D-1846-2019
Terminated recall by Alkermes Inc, reported 2019-09-04, distributed nationwide. Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2
| Recall number | D-1846-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alkermes Inc, Wilmington, OH, United States |
| Recall initiated | 2019-08-08 |
| Classified | 2019-08-29 |
| Reported by FDA | 2019-09-04 |
| Terminated | 2020-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 6,514 kits |
| Reason classes | labeling |
| 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 | 2018-3010T |
| Expiration dates | 2021-08 |
Product
Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) One vial containing 4 mL of diluent, 3) One 5-mL prepackaged syringe, 4) One 20-gauge 1-inch needle, 5) Two 20-gauge 1.5-inch safety needles, 6) Two 20-gauge 2-inch safety needles. Rx Only. Manufactured and marketed by: Alkermes, Inc. Kit NDC: 65757-300-01
Reason for recall
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
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-1846-2019. 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.