Drug recall: Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc.…

Class II FDA enforcement event 83434. Recall start date: 24 Jul 2019. Status in the FDA record: Terminated. Termination date: 4 Aug 2021.

Reason for recall, in the words of FDA

Failed dissolution specifications

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Alvogen, Inc started this drug recall on 24 Jul 2019. The firm address in the FDA record is in Pine Brook, NJ. FDA put the recall in Class II. FDA event 83434 has 2 product records. The first FDA enforcement report date is 21 Aug 2019. The record gives the status Terminated, with the termination date 4 Aug 2021.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Natonwide, PR

Recalling firm

Alvogen, Inc, Pine Brook, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 83434: product records
Recall number	Product	Quantity	Class	Status	Report date
D-1722-2019	Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01	2784 bottles	Class II	Terminated	21 Aug 2019
D-1723-2019	Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 52427-285-01	4272 bottles	Class II	Terminated	21 Aug 2019

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2019: 362
Share of these events in Class II: 68%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 10

Other events of the firm

Other FDA enforcement events of Alvogen, Inc
Initiated	Product (first record)	Type	Class	Records
31 Dec 2025	Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah,	Drug	Class II	1
31 Jan 2025	Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed	Drug	Class I	1
6 Feb 2023	Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 5	Drug	Class II	1
26 Feb 2021	Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvo	Drug	Class II	1
19 Apr 2019	FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine	Drug	Class I	1
16 Jun 2017	Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen	Drug	Class II	3
7 Mar 2017	Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 070	Drug	Class III	9
21 Apr 2015	NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pi	Drug	Class II	1
28 Aug 2014	Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals	Drug	Class II	1

Alvogen, Inc: all 10 events

Official channels

FDA enforcement report D-1722-2019The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 83434. https://recallregister.com/fda/ii/83434/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Natonwide, PR
What quantity of product is in FDA event 83434?: The event has 2 product records. The first record gives this quantity: 2784 bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2019 have the same class?: 68% of the 362 drug events that started in 2019 are in Class II.