Nizatidine recalls

The FDA has published 3 recalls involving Nizatidine since 2020. The latest was reported on 6 May 2020. Most were for nitrosamine impurity. Mylan Pharmaceuticals 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 recalls3since 2020

Last 12 months0reported

Class I00% of total

Ongoing0latest 6 May 2020

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 3 100%Class III 0 0%

Why nizatidine is recalled

Nitrosamine Impurity3100%

Companies

By year

20203100%

All nizatidine recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
6 May 2020Drug	CLASS II	Nizatidine Oral Solution, 15 mg/mL (75 mg recalledNizatidine	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
29 Jan 2020Drug	CLASS II	Nizatidine Capsules, USP 300 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Nitrosamine Impurity	Nationwide
29 Jan 2020Drug	CLASS II	Nizatidine Capsules, USP 150 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Nitrosamine Impurity	Nationwide

Should you stop taking Nizatidine?

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.