CLASS II Drug recall · Reported 18 Jul 2018 · FDA Enforcement Report
Nitrofurantoin Oral Suspension USP, 25mg recalled by Lupin Somerset
Lupin Somerset is recalling Nitrofurantoin Oral Suspension USP, 25mg, distributed nationwide in the US. The recall was initiated on 28 Jun 2018 and the FDA has classified it as Class II.
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-0927-2018
- FDA event ID
- 80377
- Recalling firm
- Lupin Somerset, Somerset, NJ
- Brand
- Nitrofurantoin
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jun 2018
- FDA classified
- 18 Jul 2018
- Reported
- 18 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 28 Jun 2018 | Recall initiated by company | |
| 18 Jul 2018 | Classified by FDA | +20 days |
| 18 Jul 2018 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug and Failed Content Uniformity.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11
Where it was distributed
Nationwide within the US
Questions about this recall
Why was it recalled?
Subpotent Drug and Failed Content Uniformity.
Which lots are affected?
Lot#: S700065, Exp. 02/2019; 700619, Exp. 08/2019
Where was it sold?
Nationwide within the US
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from Lupin Somerset
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Morphine Sulfate Extended-Release Tablets, 30 mg recalledMorphine Sulfate | Lupin Somerset | Potency & Assay | Nationwide |
| Drug | CLASS III | Morphine Sulfate Extended-Release Tablets, 15 mg recalledMorphine Sulfate | Lupin Somerset | Potency & Assay | Nationwide |
| Drug | CLASS III | Morphine Sulfate Extended-Release Tablets, 200 mg recalledMorphine Sulfate | Lupin Somerset | Potency & Assay | Nationwide |
| Drug | CLASS III | Morphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine Sulfate | Lupin Somerset | Potency & Assay | Nationwide |
| Drug | CLASS III | Morphine Sulfate Extended-Release Tablets, 60 mg recalledMorphine Sulfate | Lupin Somerset | Potency & Assay | Nationwide |
Other Nitrofurantoin recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nitrofurantoin Capsules, USP, 100 mg Dose recalled by AvKARE | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS III | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg recalled | Alvogen | Potency & Assay | PR |
| Drug | CLASS II | Nitrofurantoin Oral Suspension, USP, 25mg recalled by Lupin SomersetNitrofurantoin | Lupin Somerset | Potency & Assay | Nationwide |
| Drug | CLASS III | Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg recalled | RemedyRepack | Foreign Material | PA |