Metformin ER Tablet Recall Information

On May 28, 2020, the FDA announced their request that five manufacturers of metformin extended-release (ER) tablets voluntarily recall their products.

June 29, 2020  

There are other manufacturers of metformin ER that are not being recalled at this time.  This recall was issued because an unexpected impurity was found in these products that may cause health risks.

What do you need to do?

 
  • Do not stop taking your medication without speaking with your doctor. The U.S. Food and Drug Administration (FDA) recommends that patients continue taking their medication, as the risk of harm to a patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
  • Please call your pharmacist to see if you were dispensed one of the impacted products. Your pharmacist will be able to tell you if you were dispensed one of the recalled manufacturers and will let you know if you need to contact your doctor for a new prescription. If needed, you could then call your doctor to obtain a new prescription for another medication so you can continue treating your condition without interruption. Please note: Watch for updates from the FDA and your local pharmacy as more manufacturers could be subjected to the recall as more testing and information could become available.
  • In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert or follow the agency’s recommended steps, which include ways to safely dispose of these medications at home. FDA recommended steps for safe drug disposal at home can be found at www.fda.gov.

For more information or to report any adverse events or quality problems experienced with the use of this product may be made at the FDA website www.fda.gov.

To report an adverse event to the FDA Med Watch Program:

 

Individual Manufacturer Information:

  • Apotex: Consumers with questions regarding this recall can contact Apotex Corp. by phone at 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com.
  • Amneal Pharmaceuticals LLC: For information concerning this recall please call Amneal at 1-833-582-0812 or email to AmnealProductRecallDS@amneal.com, Monday – Friday, 8:00 am – 5:00 pm, EST.
  • Marksans Pharma Limited: Consumers with questions regarding this recall and return can contact Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc., located at 7 Michael Avenue, Farmingdale, New York 11735, by phone number 631-753-9090; ext. 160, [Monday to Friday 8am-5pm EST] or e-mail address imcgregor@timecaplabs.com.
  • Lupin Pharmaceuticals Inc: Consumers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (855) 532-1856 Monday – Friday 09:00 am to 05:00 pm EST
  • Teva Pharmaceuticals USA, Inc: Consumers with medical-related questions, who wish to report an adverse event, or quality issues about the Teva products being recalled should contact Teva Medical Information by phone at: 888-838-2872, option 3, then, option 4. Live calls are received Monday-Friday, 9:00 am to 5:00 pm Eastern Time with voicemail available 24 hours/day, 7 days/week or by email at druginfo@tevapharm.com.