Reported May 23, 2018 · Terminated

Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by:…

Sun Pharmaceutical Industries, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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. · 270 Prospect Plains Rd · Cranbury, NJ · 08512-3605

Is this the product you have?

  • Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle
  • Manufactured byMikart, Inc., Atlanta, GA 30318
  • Distributed bySun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02
Lot codes and dates
  • Lot Numbers
    • E170210A
    • EXP 06/09/2019
    • F170214A
    • 07/05/2019
    • F170223A
    • EXP 07/06/2019
    • F170224A EXP 07/10/2019
    • F170231A
    • EXP 07/12/2019
    • F170232A EXP 07/13/2019
Amount recalled
19,758 473 mL 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

Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 28, 2019 · Data as of Sep 19, 7:16 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.