Nitrofurantoin recalls

The FDA has published 10 recalls involving Nitrofurantoin since 2014. The latest was reported on 8 Jan 2025. Most were for potency & assay. Alvogen 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 2014

Last 12 months0reported

Class I00% of total

Ongoing1latest 8 Jan 2025

Recalls per month, last 24 months

click a bar for that month

0Dec '24 1 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0

Severity split

Class I 0 0%Class II 7 70%Class III 3 30%

Why nitrofurantoin is recalled

Companies

By year

2025110%
2022110%
2019220%
2018330%
2016110%
2015110%
2014110%

Ongoing nitrofurantoin recalls

1 active

Reported	Class	Recall	Company	Reason	Where
8 Jan 2025Drug	CLASS II	Nitrofurantoin Capsules, USP, 100 mg Dose recalled by AvKARE	AvKARE	Potency & Assay	Nationwide

All nitrofurantoin recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
8 Jan 2025Drug	CLASS II	Nitrofurantoin Capsules, USP, 100 mg Dose recalled by AvKARE	AvKARE	Potency & Assay	Nationwide
25 May 2022Drug	CLASS III	Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) recalled	American Health Packaging	Potency & Assay	Nationwide
21 Aug 2019Drug	CLASS II	Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg recalled	Alvogen	Potency & Assay	PR
9 Jan 2019Drug	CLASS II	Nitrofurantoin Oral Suspension, USP, 25mg recalled by Lupin SomersetNitrofurantoin	Lupin Somerset	Potency & Assay	Nationwide
5 Dec 2018Drug	CLASS III	Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg recalled	RemedyRepack	Foreign Material	PA
21 Nov 2018Drug	CLASS III	Nitrofurantoin Capsules recalled by Sandoz	Sandoz	Other	Nationwide
18 Jul 2018Drug	CLASS II	Nitrofurantoin Oral Suspension USP, 25mg recalled by Lupin SomersetNitrofurantoin	Lupin Somerset	Potency & Assay	Nationwide
22 Jun 2016Drug	CLASS II	Nitrofurantoin Oral Suspension, USP, 25 mg recalled	Nostrum Laboratories	Potency & Assay	Nationwide
20 May 2015Drug	CLASS II	Nitrofurantoin Monohydrate/Macrocrystals Capsules, 100 mg recalled	Alvogen	Potency & Assay	Nationwide
22 Jan 2014Drug	CLASS II	Nitrofurantoin Monohydrate/ Macrocrystals Capsule, 100 mg recalled	Aidapak Services	Labeling Errors	4 states

Should you stop taking Nitrofurantoin?

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.