Reported Jul 8, 2020 · Terminated

Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc.,…

Preferred Pharmaceuticals, 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: Preferred Pharmaceuticals, Inc. · 1250 N Lakeview Ave Ste O · Anaheim, CA · 92807-1801

Is this the product you have?

  • Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100
  • MfgTime-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim
  • CA NDC68788-6932-01
Lot codes and dates
    • J0119M
    • K1419L
    • K2719J
    • A0220H
    • Exp. Date 12/2020
Amount recalled
144 bottles

Where it was sold

Why it was recalled

CGMP Deviations: FDA analysis detected 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 Mar 21, 2024 · Data as of Sep 19, 5:04 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.