Naltrexone recalls

The FDA has published 10 recalls involving Naltrexone since 2013. The latest was reported on 15 Jun 2022. Alkermes has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls10since 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 15 Jun 2022

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 8 80%Class III 2 20%

Why naltrexone is recalled

Companies

Alkermes440%
Orexigen Therapeutics220%
Beacon Hill Medical Pharmacy, P.C110%
Mckesson Medical-Surgical Inc. Corporate Office110%
The Medicine Shoppe Pharmacy110%
Mprx110%

Brands

By year

2022110%
2020220%
2019220%
2018220%
2014110%
2013220%

All naltrexone recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
15 Jun 2022Drug	CLASS II	Naltrexone Hydrochloride Tablets, USP, 50 mg recalledNaltrexone Hydrochloride	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
22 Apr 2020Drug	CLASS II	Naltrexone 4.5 mg/mL Suspension, Rx recalled	The Medicine Shoppe Pharmacy	Other	FL
5 Feb 2020Drug	CLASS II	Naltrexone 4.5 mg capsule recalled by MPRX	Mprx	Other	TX
9 Oct 2019Drug	CLASS II	Vivitrol (naltrexone for extended-release injectable recalledVivitrol	Alkermes	Packaging Defects	Nationwide
4 Sep 2019Drug	CLASS II	Vivitrol (naltrexone for extended-release injectable recalledVivitrol	Alkermes	Packaging Defects	Nationwide
14 Nov 2018Drug	CLASS III	Contrave (naltrexone HCl and bupropion HCl) recalledContrave	Orexigen Therapeutics	Packaging Defects	CA
22 Aug 2018Drug	CLASS III	Contrave (naltrexone HCl and bupropion HCl) recalledContrave	Orexigen Therapeutics	Other	Nationwide
3 Sep 2014Drug	CLASS II	Vivitrol (naltrexone for extended-release injectable suspension) recalledVivitrol	Alkermes	Other	Nationwide
18 Sep 2013Drug	CLASS II	Naltrexone 1 MG/ML Injectable and 200 MG/ML Injectable recalled	Beacon Hill Medical Pharmacy, P.C	Sterility	Nationwide
31 Jul 2013Drug	CLASS II	Vivitrol (naltrexone for extended-release injectable recalledVivitrol	Alkermes	Sterility	Nationwide

Should you stop taking Naltrexone?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.