Avkare ranitidine recalls

The FDA has published 4 recalls involving Avkare ranitidine since 2019. The latest was reported on 4 Dec 2019. Most were for nitrosamine impurity. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls4since 2019

Last 12 months0reported

Class I00% of total

Ongoing0latest 4 Dec 2019

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 100%Class III 0 0%

Why avkare ranitidine is recalled

Nitrosamine Impurity4100%

Companies

AVKARE4100%

By year

20194100%

All avkare ranitidine recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
4 Dec 2019Drug	CLASS II	Ranitidine Tablets, USP 300 mg recalled by AVKARE	AVKARE	Nitrosamine Impurity	Nationwide
4 Dec 2019Drug	CLASS II	Ranitidine Tablets, USP 150 mg recalled by AVKARE	AVKARE	Nitrosamine Impurity	Nationwide
6 Nov 2019Drug	CLASS II	Ranitidine Hydrochloride Capsules 300 mg recalled by AVKARE	AVKARE	Nitrosamine Impurity	CO, MO
6 Nov 2019Drug	CLASS II	Ranitidine Hydrochloride Capsules 150 mg recalled by AVKARE	AVKARE	Nitrosamine Impurity	CO, MO

Should you stop taking Avkare ranitidine?

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.