CLASS III Drug recall · Reported 21 Nov 2018 · FDA Enforcement Report
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg recalled
Sandoz is recalling Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, distributed nationwide in the US. The recall was initiated on 2 Nov 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0257-2019
- FDA event ID
- 81457
- Recalling firm
- Sandoz, Princeton, NJ
- Manufacturer
- Sandoz Inc
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Nov 2018
- FDA classified
- 20 Nov 2018
- Reported
- 21 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Antibiotics
Timeline
| 2 Nov 2018 | Recall initiated by company | |
| 20 Nov 2018 | Classified by FDA | +18 days |
| 21 Nov 2018 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross Contamination with Other Products
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Cross Contamination with Other Products
Which lots are affected?
Lots: a) JB4952, JA7322 Exp. 03/2020; b) JA7324, Exp.03/2020
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 81457| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Nitrofurantoin Capsules recalled by Sandoz | Sandoz | Other | Nationwide | |
| CLASS II | Isosorbide Dinitrate Tablets, USP 20 mg recalled by Sandoz | Sandoz | Other | Nationwide | |
| CLASS II | Isosorbide Dinitrate Tablets, USP 10 mg recalled by Sandoz | Sandoz | Other | Nationwide | |
| CLASS II | Isosorbide Dinitrate Tablets, USP 20 mg recalled by SandozIsosorbide Dinitrate | Sandoz | Other | Nationwide | |
| CLASS II | Isosorbide Dinitrate Tablets, USP 5 mg recalled by Sandoz | Sandoz | Other | Nationwide |
More recalls from Sandoz
All 46| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin | Sandoz | Other | Nationwide |
| Drug | CLASS II | Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide | Sandoz | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalledCiprofloxacin And Dexamethasone | Sandoz | Temperature Abuse | CA |
| Drug | CLASS I | Buffered Penicillin G Potassium for Injection recalled by SandozPenicillin G Potassium | Sandoz | Labeling Errors | Nationwide |
| Drug | CLASS I | Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin | Sandoz | Packaging Defects | Nationwide |
Other Nitrofurantoin (monohydrate recalls
All 3| 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 |