CLASS II Drug recall · Reported 21 Aug 2019 · FDA Enforcement Report
Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg recalled
Alvogen is recalling Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, distributed in Puerto Rico. The recall was initiated on 24 Jul 2019 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-1722-2019
- FDA event ID
- 83434
- Recalling firm
- Alvogen, Pine Brook, NJ
- Manufacturer
- Alvogen Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2019
- FDA classified
- 12 Aug 2019
- Reported
- 21 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 24 Jul 2019 | Recall initiated by company | |
| 12 Aug 2019 | Classified by FDA | +19 days |
| 21 Aug 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
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 Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01
Where it was distributed
Natonwide, PR
Questions about this recall
Why was it recalled?
Failed dissolution specifications
Which lots are affected?
Lot # 471976, Exp 03/2020
Where was it sold?
Natonwide, PR
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.
Other products in this recall event
1 other product · FDA event 83434This product is part of a recall event; the main page for the event is Macrobid Urinary Tract Anitbacterial, 100 mg recalled by Alvogen.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Macrobid Urinary Tract Anitbacterial, 100 mg recalled by AlvogenMacrobid | Alvogen | Potency & Assay | PR |
More recalls from Alvogen
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg recalled | Alvogen | Packaging Defects | Nationwide |
| Drug | CLASS I | Fentanyl Transdermal System CII, 25mcg/h recalled by AlvogenFentanyl System | Alvogen | Packaging Defects | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP 112 mcg recalled by Alvogen | Alvogen | Potency & Assay | Nationwide |
| Drug | CLASS II | Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg recalled by AlvogenBuprenorphine And Naloxone | Alvogen | Potency & Assay | Nationwide |
| Drug | CLASS II | Macrobid Urinary Tract Anitbacterial, 100 mg recalled by AlvogenMacrobid | Alvogen | Potency & Assay | PR |
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 | 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 |
| Drug | CLASS III | Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg recalled | RemedyRepack | Foreign Material | PA |