Reported Jul 18, 2018 · Terminated

Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc.…

Lupin Somerset

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: LUPIN SOMERSET · 400 Campus Dr · Somerset, NJ · 08873-1145

Is this the product you have?

  • Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only
  • Manufactured byNovel Laboratories, Inc. Somerset, NJ 08873
  • Manufactured for
    • Lupin Pharmaceuticals
    • Inc. Baltimore
    • MD 21202
    • UPC 343386-450-114
    • NDC 43386-450-11
Lot codes and dates
    • Lot#: S700065
    • Exp. 02/2019
    • 700619
    • Exp. 08/2019
Amount recalled
3456 cartons

Where it was sold

  • Nationwide

Why it was recalled

Subpotent Drug and Failed Content Uniformity.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 6, 2023 · Data as of Sep 19, 5:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.