Lower risk Drug recall · FDA · Published August 8, 2019

Alkermes Vivitrol 380mg Recall: Incorrect Needle Size in Kit

Alkermes recalls Vivitrol 380mg injectable kits due to 1-inch needles mistakenly included in the 1.5-inch sleeve. This could cause improper injection. Consumers should check their kit's needle size and contact Alkermes for guidance.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1846-2019Drug Alkermes ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmAlkermes Inc265 Olinger Cir · Wilmington, OH 45177-2484

✎ GovInfoNow plain-language explainer

Alkermes is recalling Vivitrol 380mg injectable kits because the kit contains 1-inch needles inside a cardboard sleeve labeled for 1.5-inch needles. This mismatch could lead to incorrect injection if the user tries to use the kit without noticing the needle size difference. Read more at govinfonow.com/recall/38193-alkermes-vivitrol-380mg-recall-incorrect-needle-size-in-kit.

Source Summary by GovInfoNow · govinfonow.com/recall/38193-alkermes-vivitrol-380mg-recall-incorrect-needle-size-in-kit · Updated October 5, 2026 · FDA enforcement record: FDA #D-1846-2019

Cite this page

“Alkermes Vivitrol 380mg Recall: Incorrect Needle Size in Kit.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38193-alkermes-vivitrol-380mg-recall-incorrect-needle-size-in-kit. Based on FDA recall #D-1846-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1846-2019%22&limit=1).

The FDA announced on 2019-08-08 that Alkermes Inc. is recalling Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial kits due to labeling errors involving incorrect needle placement. The agency classified the recall as Class II.

How to tell if you have it

Brand: Alkermes
Product: Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial
Kit NDC: 65757-300-01
Lot code: 2018-3010T
Expiration date: 8/2021
Quantity: 6,514 kits

The hazard

The drug product kit was recalled because 1-inch needles were placed in the 1 1/2-inch needle cardboard sleeve labeled as administration needles. The record states that the product vial is not impacted.

Context

GovInfoNow's records show Alkermes, Inc. has three other recalls on record since 2012-11-06. Other recent recalls of similar products include Meitheal Cetrorelix Acetate Injection Kit Recall (2026-02-09), Winder Morphine Sulfate Oral Solution Recall (2025-11-26), and Lupin Liraglutide 18mg/3mL Injection Recall (2026-04-24).

How to tell if you have this one

Check your Vivitrol kit for a cardboard sleeve labeled as 'administration needles' with 1.5-inch needles. The kit should have NDC 65757-300-01 and lot number 2018-3010T (expiring 8/2021).

Brand
Alkermes
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Needle Size
Look for a cardboard sleeve labeled as 'administration needles' that contains 1-inch needles instead of 1.5-inch needles.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Distributed Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

Aug 8, 2019Firm started the recall
Aug 29, 2019FDA classified it Class II
Sep 4, 2019Published in FDA’s Enforcement Report
Nov 6, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/38193-alkermes-vivitrol-380mg-recall-incorrect-needle-size-in-kit">Alkermes Vivitrol 380mg Recall: Incorrect Needle Size in Kit (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1846-2019 (August 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1846-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.