CLASS II Drug recall · Reported 22 Jun 2016 · FDA Enforcement Report
Nitrofurantoin Oral Suspension, USP, 25 mg recalled
Nostrum Laboratories is recalling Nitrofurantoin Oral Suspension, USP, 25 mg/, For Oral Use Only, Urinary Tract, distributed nationwide in the US. The recall was initiated on 23 May 2016 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-1030-2016
- FDA event ID
- 74194
- Recalling firm
- Nostrum Laboratories, Bryan, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 May 2016
- FDA classified
- 14 Jun 2016
- Reported
- 22 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 23 May 2016 | Recall initiated by company | |
| 14 Jun 2016 | Classified by FDA | +22 days |
| 22 Jun 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
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, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
BZP0093A, BZP0094A, BZP0095A, BZP0096A, BZP0097A, Exp 02/2017
Where was it sold?
Nationwide
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 Nostrum Laboratories
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sucralfate Tablets recalled by Nostrum Laboratories | Nostrum Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled | Nostrum Laboratories | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled | Nostrum Laboratories | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg recalled | Nostrum Laboratories | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg recalled | Nostrum Laboratories | Nitrosamine Impurity | 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 II | Nitrofurantoin Oral Suspension, USP, 25mg recalled by Lupin SomersetNitrofurantoin | Lupin Somerset | Potency & Assay | Nationwide |