Vivitrol (Alkermes) – dose delivery failure (2014)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451.
Brand
Alkermes, Inc.
Lot Codes / Batch Numbers
Batch Number: 412-3732AA, expiration date 07/2016 (NDC# 65757-302-02, Kit Pacaging Lot Number: 2013-021, expiration date 07/2016 (NDC# 65757-300-01.
Products Sold
Batch Number: 412-3732AA; expiration date 07/2016 (NDC# 65757-302-02; Kit Pacaging Lot Number: 2013-021; expiration date 07/2016 (NDC# 65757-300-01.
Alkermes, Inc. is recalling VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX due to Customer complaints for failure to deliver the dose.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Customer complaints for failure to deliver the dose.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026