Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

VIVITROL (naltrexone for extended-release injectable suspension) Recalled by Alkermes, Inc. Due to Customer complaints for failure to deliver the dose.

Date: March 4, 2014
Company: Alkermes, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Alkermes, Inc. directly.

Affected Products

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.

Quantity: 4,364 vials

Why Was This Recalled?

Customer complaints for failure to deliver the dose.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Alkermes, Inc.

Alkermes, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report