Reported Mar 15, 2023 · Terminated

Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis…

Teva Pharmaceuticals USA 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: Teva Pharmaceuticals USA Inc · 400 Interpace Pkwy Bldg A · Parsippany, NJ · 07054-1120

Is this the product you have?

  • Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only
  • Manufactured byActavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA
  • Distributed byActavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60
Lot codes and dates
    • Lot #: 1410946A
    • Exp. 06/2023
Amount recalled
12,044 Bottles

Where it was sold

Why it was recalled

CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

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 Dec 6, 2023 · Data as of Sep 19, 7:21 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.