CLASS II Drug recall · Reported 4 Sep 2019 · FDA Enforcement Report
Vivitrol (naltrexone for extended-release injectable recalled
Alkermes is recalling Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial, distributed nationwide in the US. The recall was initiated on 8 Aug 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1846-2019
- FDA event ID
- 83511
- Recalling firm
- Alkermes, Wilmington, OH
- Brand
- Vivitrol
- Manufacturer
- Alkermes, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Aug 2019
- FDA classified
- 29 Aug 2019
- Reported
- 4 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Aug 2019 | Recall initiated by company | |
| 29 Aug 2019 | Classified by FDA | +21 days |
| 4 Sep 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial recalled?
Yes. Alkermes recalled Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial on 8 Aug 2019. The recall is Class II and its status is Terminated. Recall number D-1846-2019.
Why was it recalled?
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.
Which lots are affected?
Lot 2018-3010T Exp 8/2021
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Alkermes
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vivitrol (naltrexone for extended-release injectable recalledVivitrol | Alkermes | Packaging Defects | Nationwide |
| Drug | CLASS II | Vivitrol (naltrexone for extended-release injectable suspension) recalledVivitrol | Alkermes | Other | Nationwide |
| Drug | CLASS II | Vivitrol (naltrexone for extended-release injectable recalledVivitrol | Alkermes | Sterility | Nationwide |
Other Naltrexone recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Naltrexone Hydrochloride Tablets, USP, 50 mg recalledNaltrexone Hydrochloride | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vivitrol (naltrexone for extended-release injectable recalledVivitrol | Alkermes | Packaging Defects | Nationwide |
| Drug | CLASS II | Naltrexone HCl USP (Dihydrate) for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
| Drug | CLASS II | Vivitrol (naltrexone for extended-release injectable suspension) recalledVivitrol | Alkermes | Other | Nationwide |
| Drug | CLASS II | Vivitrol (naltrexone for extended-release injectable recalledVivitrol | Alkermes | Sterility | Nationwide |