Drug recall: Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC…

Class II FDA enforcement event 81457. Recall start date: 2 Nov 2018. Status in the FDA record: Terminated. Termination date: 2 Oct 2020.

Reason for recall, in the words of FDA

Cross Contamination with Other Products

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

Sandoz Inc started this drug recall on 2 Nov 2018. The firm address in the FDA record is in Princeton, NJ. FDA put the recall in Class II. FDA event 81457 has 6 product records. The first FDA enforcement report date is 21 Nov 2018. The record gives the status Terminated, with the termination date 2 Oct 2020.

FDA enforcement report The 6 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.

Nationwide within the United States

Recalling firm

Sandoz Inc, Princeton, NJ.

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

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

Products

6 product records in the event.

FDA event 81457: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0257-2019	Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540	14366 bottles	Class III	Terminated	21 Nov 2018
D-0258-2019	Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01	18,832 bottles	Class II	Terminated	21 Nov 2018
D-0259-2019	Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00	7817 bottles	Class II	Terminated	21 Nov 2018
D-0260-2019	Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-225-00	5100 bottles	Class II	Terminated	21 Nov 2018
D-0261-2019	Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00	1550 bottles	Class II	Terminated	21 Nov 2018
D-0262-2019	Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC 16714-439-01	23053 bottles	Class III	Terminated	21 Nov 2018

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 2018: 367
Share of these events in Class II: 60%
Product records in this event: 6Median of the firm: 1
Events of the firm on the register: 30

Other events of the firm

Other FDA enforcement events of Sandoz Inc
Initiated	Product (first record)	Type	Class	Records
1 Jun 2026	Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDM	Drug	Class III	1
5 Sep 2025	Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactur	Drug	Class II	1
13 Aug 2025	Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manuf	Drug	Class II	1
27 Jun 2025	Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by S	Drug	Class I	2
21 Mar 2022	Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton,	Drug	Class II	1
17 Nov 2021	Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Inje	Drug	Class I	1
21 Apr 2020	Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed	Drug	Class II	1
17 Oct 2019	Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC	Drug	Class III	3
23 Sep 2019	Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of	Drug	Class II	3
1 Nov 2018	Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug	Drug	Class II	1

Sandoz Inc: all 30 events

Official channels

FDA enforcement report D-0257-2019The 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 81457. https://recallregister.com/fda/ii/81457/. 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: Nationwide within the United States
What quantity of product is in FDA event 81457?: The event has 6 product records. The first record gives this quantity: 14366 bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2018 have the same class?: 60% of the 367 drug events that started in 2018 are in Class II.