Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial Recalled by Alkermes, Inc. Due to Lack of Assurance of Sterility: Product did not...
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) 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,
Quantity: 3,325 vials
Why Was This Recalled?
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Alkermes, Inc.
Alkermes, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report