Alkermes Recalls Vivitrol Kits Due to Incorrect Needle Packaging
Alkermes is recalling 6,514 Vivitrol kits because 1-inch needles were incorrectly placed in sleeves labeled for 1.5-inch needles. The drug vials are not impacted.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the product vial is not impacted and the issue is limited to needle packaging/labeling, fitting the criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Alkermes Inc is recalling 6,514 kits of Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. The recall is due to a labeling and packaging error where 1-inch needles were placed in the cardboard sleeve labeled for 1.5-inch administration needles. The product vials themselves are not impacted by this issue.
The affected product is identified by Lot 2018-3010T with an expiration date of 8/2021. The kits were distributed nationwide in the USA. Each kit contains one vial of Vivitrol, one vial of diluent, one 5-mL prepackaged syringe, one 20-gauge 1-inch needle, two 20-gauge 1.5-inch safety needles, and two 20-gauge 2-inch safety needles.
Consumers and healthcare providers should check their inventory for Vivitrol kits with Lot 2018-3010T. If found, they should stop using the kits and contact Alkermes Inc for further instructions on how to return the product.
The recalled product
- Product
- VIVITROL (NALTREXONE)
- Brand
- VIVITROL
- Manufacturer
- Alkermes Inc
- Category
- Drug — Prescription Injectable
- Affected units
- 6,514
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 2018-3010T Exp 8/2021
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · VIVITROL
- ModerateAlkermes Recalls Vivitrol Kits Due to Needle Labeling Error
FDA (Drugs) · 2019-10-09
- SevereAlkermes Recalls VIVITROL Vials Due to Dose Delivery Failure
FDA (Drugs) · 2014-09-03
- HighAlkermes Recalls VIVITROL Vials Due to Sterility Assurance Concerns
FDA (Drugs) · 2013-07-31
Same hazard · mis labeling
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02