CLASS II Drug recall · Reported 9 Jan 2019 · 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 21 Dec 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-0346-2019
- FDA event ID
- 81865
- Recalling firm
- Lupin Somerset, Somerset, NJ
- Brand
- Nitrofurantoin
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Dec 2018
- FDA classified
- 31 Dec 2018
- Reported
- 9 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 21 Dec 2018 | Recall initiated by company | |
| 31 Dec 2018 | Classified by FDA | +10 days |
| 9 Jan 2019 | Published in enforcement report | +9 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: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
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, NDC 43386-450-11.
Where it was distributed
Nationwide in the USA and Puerto Rico.
Questions about this recall
Why was it recalled?
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Which lots are affected?
Lot #: S700038, S700044, S700059, S700065, Exp 28-Feb-19; S700410, S700427, Exp 30-Jun-19; S700617, S700619, Exp 31-Aug-19; S700813, S700815, S700869, Exp 31-Oct-19; S700871, S700873, Exp 30-Nov-19; S700875, S701073, Exp 31-Dec-19.
Where was it sold?
Nationwide in the USA and Puerto Rico.
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 11| 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 recalledNitrofurantoin Monohydrate/ Macrocrystalline | Alvogen | Potency & Assay | PR |
| Drug | CLASS II | Macrobid Urinary Tract Anitbacterial, 100 mg recalled by AlvogenMacrobid | Alvogen | Potency & Assay | PR |
| Drug | CLASS III | Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg recalled | RemedyRepack | Foreign Material | PA |