CLASS II Drug recall · Reported 31 Jul 2013 · FDA Enforcement Report
Vivitrol (naltrexone for extended-release injectable recalled
Alkermes is recalling Vivitrol (naltrexone for extended-release injectable suspension) a) 380 mg vial, distributed nationwide in the US. The recall was initiated on 6 Nov 2012 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-819-2013
- FDA event ID
- 65092
- Recalling firm
- Alkermes, Waltham, MA
- Brand
- Vivitrol
- Manufacturer
- Alkermes, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Nov 2012
- FDA classified
- 24 Jul 2013
- Reported
- 31 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Nov 2012 | Recall initiated by company | |
| 24 Jul 2013 | Classified by FDA | +260 days |
| 31 Jul 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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,
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Which lots are affected?
Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13
Where was it sold?
Nationwide
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 26 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 recalledVivitrol | Alkermes | Packaging Defects | Nationwide |
| Drug | CLASS II | Vivitrol (naltrexone for extended-release injectable suspension) recalledVivitrol | Alkermes | Other | Nationwide |
Other Naltrexone recalls
All 10| 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 | Naltrexone 4.5 mg/mL Suspension, Rx recalled | The Medicine Shoppe Pharmacy | Other | FL |
| Drug | CLASS II | Naltrexone 4.5 mg capsule recalled by MPRX | Mprx | Other | TX |
| Drug | CLASS II | Vivitrol (naltrexone for extended-release injectable recalledVivitrol | Alkermes | Packaging Defects | Nationwide |
| Drug | CLASS II | Vivitrol (naltrexone for extended-release injectable recalledVivitrol | Alkermes | Packaging Defects | Nationwide |