Reported Oct 21, 2015 · Terminated

Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by

Actavis Laboratories, FL, 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: Actavis Laboratories, FL, Inc. · 4955 Orange Dr · Davie, FL · 33314-3902

Is this the product you have?

Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by

4 of 4 products

Products covered by this recall
#Product as published
1Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA
2Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA
3NDC 0591-2720-60
4UPC 3 05912 72060 3.
Lot codes and dates
  • Lot
    • 1037736A
    • Exp 03/18
Amount recalled
13,284 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.

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 Apr 10, 2017 · Data as of Sep 19, 5:49 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.