Metformin ER Tablet Recall Information
On May 28, 2020, the U.S. Food and Drug Administration (FDA) asked five makers of metformin extended-release (ER) tablets to remove their products from the market.
There are other makers of metformin ER that are not being asked to remove their product from the market at this time. This step was taken when an impurity that may cause health risks was found in these drugs.
What do you need to do?
- Do not stop taking the drug on your own. The FDA recommends that you should keep taking your medication until you talk with you provider. The risk of harm to your health may be higher if you stop taking your drug without switching to another treatment.
- Please call your pharmacist to see if they filled your prescription with one of the impacted products. Your pharmacist will be able to tell you if they filled your prescription with medicine from one of the drug makers being asked to remove their product from the market. The pharmacist will let you know if you need to contact your healthcare provider for a new prescription. If needed, call your healthcare provider to obtain a new prescription for another medication so you can keep treating your health issue without any breaks. Please note: Watch for updates from the FDA and your local pharmacy. More drug makers may have to remove their products from the market as more testing and information becomes available.
- In light of COVID-19, the FDA recommends that you do not take your medicines to a drug take-back site. Instead, follow the disposal steps in the medication guide or package insert. Or go to www.fda.gov. Follow the FDA steps to dispose of drugs safely at home.
You also can go to the FDA’s site to:
- Learn more about this recall
- Report any quality problems you had with this product
- Report any adverse events with this drug to the FDA Med Watch program.
You can report:
Individual Drug Maker 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 firstname.lastname@example.org.
- 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 email@example.com.