Reported Nov 11, 2020 · Ongoing

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum…

Nostrum Laboratories Inc.

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: Nostrum Laboratories Inc · 1800 N Topping Ave · Kansas City, MO · 64120-1228

Is this the product you have?

  • Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only
  • Manufactured byNostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01
Lot codes and dates
    • MET200101
    • MET200301 EXP 05/2022
Amount recalled
12,967 bottles

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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

Data as of Sep 19, 5:07 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.