CLASS III Drug recall · Reported 21 Nov 2018 · FDA Enforcement Report

Nitrofurantoin Capsules recalled by Sandoz

Sandoz is recalling Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg bottoles, distributed nationwide in the US. The recall was initiated on 2 Nov 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: JA7319, JA 7320, JA7321, Exp. 03/2020

Quantity recalled23053 bottles

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-0262-2019
FDA event ID: 81457
Recalling firm: Sandoz, Princeton, NJ
Classification: Class III
Status: Terminated
Recall initiated: 2 Nov 2018
FDA classified: 20 Nov 2018
Reported: 21 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Antibiotics

Timeline

2 Nov 2018	Recall initiated by company
20 Nov 2018	Classified by FDA	+18 days
21 Nov 2018	Published in enforcement report	+1 day

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Cross Contamination with Other Products

Product as listed by the FDA

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

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

Cross Contamination with Other Products

Which lots are affected?

Lot #: JA7319, JA 7320, JA7321, Exp. 03/2020

Where was it sold?

Nationwide within the United States

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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

5 other products · FDA event 81457

This product is part of a recall event; the main page for the event is Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg recalled.

Reported	Class	Recall	Company	Reason	Where
21 Nov 2018	CLASS III	Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg recalledNitrofurantoin (monohydrate/macrocrystals)	Sandoz	Packaging Defects	Nationwide
21 Nov 2018	CLASS II	Isosorbide Dinitrate Tablets, USP 20 mg recalled by Sandoz	Sandoz	Other	Nationwide
21 Nov 2018	CLASS II	Isosorbide Dinitrate Tablets, USP 10 mg recalled by Sandoz	Sandoz	Other	Nationwide
21 Nov 2018	CLASS II	Isosorbide Dinitrate Tablets, USP 20 mg recalled by SandozIsosorbide Dinitrate	Sandoz	Other	Nationwide
21 Nov 2018	CLASS II	Isosorbide Dinitrate Tablets, USP 5 mg recalled by Sandoz	Sandoz	Other	Nationwide

More recalls from Sandoz

All 59

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Drug	CLASS III	Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin	Sandoz	Other	Nationwide
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9 Jul 2025Drug	CLASS I	Buffered Penicillin G Potassium for Injection recalled by SandozPenicillin G Potassium	Sandoz	Labeling Errors	Nationwide
9 Jul 2025Drug	CLASS I	Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin	Sandoz	Packaging Defects	Nationwide

Other Nitrofurantoin recalls

All 11

Reported	Class	Recall	Company	Reason	Where
8 Jan 2025Drug	CLASS II	Nitrofurantoin Capsules, USP, 100 mg Dose recalled by AvKARE	AvKARE	Potency & Assay	Nationwide
25 May 2022Drug	CLASS III	Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) recalled	American Health Packaging	Potency & Assay	Nationwide
21 Aug 2019Drug	CLASS II	Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg recalledNitrofurantoin Monohydrate/ Macrocrystalline	Alvogen	Potency & Assay	PR
21 Aug 2019Drug	CLASS II	Macrobid Urinary Tract Anitbacterial, 100 mg recalled by AlvogenMacrobid	Alvogen	Potency & Assay	PR
9 Jan 2019Drug	CLASS II	Nitrofurantoin Oral Suspension, USP, 25mg recalled by Lupin SomersetNitrofurantoin	Lupin Somerset	Potency & Assay	Nationwide