FDAClass IIIRecall started November 2, 2018

Nitrofurantoin Capsules 100 mg (D-0257-2019) Recall: Contamination

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

What is the FDA recall status?

The FDA record lists this recall as terminated. This does not establish that a retained recalled product is safe to consume or use. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions.

How FDA enforcement data reports status

Why was Nitrofurantoin Capsules 100 mg recalled?

Cross Contamination with Other Products

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full product description

Which lot codes, UPCs or models are affected?

Lots: a) JB4952, JA7322 Exp. 03/2020; b) JA7324, Exp.03/2020

Agency record number: D-0257-2019
Product: 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
Recalling firm: Sandoz Inc
Quantity: 14366 bottles
Distribution: Nationwide within the United States
Recall started: November 2, 2018
Report date: November 21, 2018
Classification: Class III
Status: Terminated
Agency: FDA (drug)

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