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Class III · Lower riskRecall completed

Nitrofurantoin (Monohydrate/Macrocrystals)

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLots: a) JB4952, JA7322 Exp. 03/2020; b) JA7324, Exp.03/2020
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Cross Contamination with Other Products

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySandoz Inc
Brand nameNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Generic nameNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Active ingredient(s)NITROFURANTOIN, NITROFURANTOIN MONOHYDRATE
Distributed by / forSandoz Inc. Princeton, NJ 08540
NDC0185-0122-01
Show the full FDA record
Full product labelNitrofurantoin 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 firmSandoz Inc
DistributionNationwide within the United States
Quantity14366 bottles
Recall initiated2018-11-02
Report date2018-11-21
Recall completed2020-10-02
Recall numberD-0257-2019
ClassificationClass III
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.