Reported May 19, 2021 · Terminated

Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun…

Sun Pharmaceutical Industries 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: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620

Is this the product you have?

  • Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only
  • Distributed bySun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
  • Manufactured bySun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-142-02
Lot codes and dates
    • Lots #: JKX2749A
    • JKX2803A
    • JKX2804A
    • JKX2805A
    • JKX806A
    • JKX2945A
    • JKX2946A
    • JXK2947A
    • JKX2948A
    • JKX2952A
    • JKX2953A
    • JKX2954A & JKX3224A
    • Exp 6/2032
    • JKX3211A
    • JKX3212A
    • Exp 7/2023
Amount recalled
50868 bottles

Where it was sold

  • Nationwide

Why it was recalled

Presence of foreign substance: identified as activated carbon.

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 Jun 27, 2023 · Data as of Sep 19, 8:06 PM UTC

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