Nitrofurantoin (monohydrate recalls
The FDA has published 3 recalls involving Nitrofurantoin (monohydrate since 2018. The latest was reported on 27 Jan 2021. Most were for packaging defects. American Health Packaging 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 2018
Last 12 months0reported
Class I00% of total
Ongoing0latest 27 Jan 2021
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 1 33%Class III 2 67%
Why nitrofurantoin (monohydrate is recalled
Companies
By year
All nitrofurantoin (monohydrate recalls, newest first
3 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals) recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals) recalled | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS III | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg recalledNitrofurantoin (monohydrate/macrocrystals) | Sandoz | Packaging Defects | Nationwide |
Should you stop taking Nitrofurantoin (monohydrate?
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.