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) 380 mg/vial. Each Carton Recalled by Alkermes, Inc. Due to Labeling: Not Elsewhere Classified. Drug product kit recalled...
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. 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
Quantity: 16,231 kits
Why Was This 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.
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