CLASS II Drug recall · Reported 3 Sep 2014 · FDA Enforcement Report
Vivitrol (naltrexone for extended-release injectable suspension) recalled
Alkermes is recalling Vivitrol (naltrexone for extended-release injectable suspension), distributed nationwide in the US. The recall was initiated on 4 Mar 2014 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-1556-2014
- FDA event ID
- 67838
- Recalling firm
- Alkermes, Waltham, MA
- Brand
- Vivitrol
- Manufacturer
- Alkermes, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Mar 2014
- FDA classified
- 22 Aug 2014
- Reported
- 3 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 4 Mar 2014 | Recall initiated by company | |
| 22 Aug 2014 | Classified by FDA | +171 days |
| 3 Sep 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Customer complaints for failure to deliver the dose.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Customer complaints for failure to deliver the dose.
Which lots are affected?
Batch Number: 412-3732AA; expiration date 07/2016 (NDC# 65757-302-02; Kit Pacaging Lot Number: 2013-021; expiration date 07/2016 (NDC# 65757-300-01.
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 recalledVivitrol | Alkermes | Sterility | 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 |