Lower risk Drug recall · FDA · Published September 26, 2019

Alkermes Vivitrol 380mg Recall: 1-inch needles in 1.5-inch sleeve

Alkermes recalls Vivitrol 380mg injectable kits due to 1-inch needles being placed in a 1.5-inch sleeve. This could cause incorrect needle use during administration. Affected kits have specific NDC and lot numbers.

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

🇺🇸 FDA recall #D-0119-2020Drug 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, Inc.852 Winter St · Waltham, MA 02451-1420

✎ GovInfoNow plain-language explainer

Alkermes is recalling Vivitrol 380mg injectable kits because the 1-inch needles are incorrectly placed in a 1.5-inch cardboard sleeve. This could lead to using the wrong needle size during injection, potentially causing injury. The recall affects kits with specific NDC and lot numbers. Read more at govinfonow.com/recall/37903-alkermes-vivitrol-380mg-recall-1-inch-needles-in-1-5.

Source Summary by GovInfoNow · govinfonow.com/recall/37903-alkermes-vivitrol-380mg-recall-1-inch-needles-in-1-5 · Updated October 5, 2026 · FDA enforcement record: FDA #D-0119-2020

Cite this page

“Alkermes Vivitrol 380mg Recall: 1-inch needles in 1.5-inch sleeve.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37903-alkermes-vivitrol-380mg-recall-1-inch-needles-in-1-5. Based on FDA recall #D-0119-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0119-2020%22&limit=1).

The FDA announced on September 26, 2019, that Alkermes, Inc. is recalling Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial kits due to a labeling hazard. The agency said the recall involves 16,231 kits distributed nationwide in the USA and Canada.

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 codes: 2019-1002T, 2019-1003T
Expiration date: 05/2021
Quantity: 16,231 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 FDA said the product vial is not impacted by this labeling error.

Context

GovInfoNow's records show Alkermes, Inc. has 3 other recalls on record since 2012-11-06. Other recent recalls of similar products include Meitheal Cetrorelix Acetate Injection Kit Recall (2026-02-09), Lupin Liraglutide 18mg/3mL Injection Recall (2026-04-24) and American Regent Papaverine HCl Injection Recall (2026-07-24).

How to tell if you have this one

Check for kits with NDC 65757-300-01 and lot numbers 2019-1002T or 2019-1003T. The kit includes one 1-inch needle and two 1.5-inch safety needles.

Brand
Alkermes
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Verify the NDC number and lot number on the kit to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

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

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Sep 26, 2019Firm started the recall
Oct 2, 2019FDA classified it Class II
Oct 9, 2019Published in FDA’s Enforcement Report
Feb 19, 2021FDA 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/37903-alkermes-vivitrol-380mg-recall-1-inch-needles-in-1-5">Alkermes Vivitrol 380mg Recall: 1-inch needles in 1.5-inch sleeve (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-0119-2020 (September 26, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0119-2020 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.