Skip to Content

metformin FDA Alerts

The FDA Alert(s) below may be specifically about metformin or relate to a group or class of drugs which include metformin.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for metformin

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg Due to the Detection of N-Nitrosodimethylamine (NDMA)

Jun 11, 2020

Audience: Consumer, Health Professional, Pharmacy

June 11, 2020 -- Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.

Metformin Hydrochloride Extended-Release Tablets USP, 500mg is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. It is packaged in a bottle containing 60 tablets with NDC 68180-336-07. The affected lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg is included in below table:

Product Name

NDC

Lot Number

Expiration Date

Metformin Hydrochloride Extended-Release Tablets USP, 500mg 68180-336-07 G901203 12/2020

The product can be identified by the NDC and the lot number available on the side of the bottle label. Metformin Hydrochloride Extended-Release Tablets USP, 500mg was distributed nationwide in the USA to wholesalers, distributors, and mail order pharmacies.

Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, and mail order pharmacies by phone and through recall notification and is arranging for the return of all the recalled product lot. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the U.S. Food & Drug Administration, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals. Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin.

Wholesalers, distributors, and retailers that have Metformin Hydrochloride Extended-Release Tablets USP, 500mg which is being recalled should discontinue distribution of the recalled product lot immediately and return it to Inmar Rx Solutions, Inc., 635 Vine St, Winston Salem, NC 27101. Tel: (855) 532-1856.

Consumers, wholesalers, distributors, and retailers 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. For reimbursement, please have the recalled lot returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the bottle.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Lupin Pharmaceuticals

Lupin Pharmaceuticals, Inc. is the U.S. based wholly-owned subsidiary of Lupin Limited and is the 3rd largest pharmaceutical company in the U.S. based on total prescriptions. Together, all Lupin-owned entities combine to make up the 8th largest generic pharmaceutical company in the world by revenue size.Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality medications across many treatment areas. Lupin Pharmaceuticals Inc.’s branded pharmaceuticals division, is the provider of products designed to help prevent and manage women’s health conditions with serious health consequences.

Source: FDA

Apotex Corp. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets 500 mg Due to the Detection of N-nitrosodimethylamine (NDMA)

Jun 5, 2020

Audience: Consumer, Health Professional, Pharmacy

June 05, 2020 -- Apotex is expanding the previously announced Retail Level recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg that was initiated on May 29, 2020 to Consumer Level.

May 29, 2020 -- Apotex Corp is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg within expiry to retail level.

Apotex was notified by the U.S. Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) and recommended recall of the one tested lot. Apotex Corp has agreed to recall this lot, and out of an abundance of caution, the company is extending the recall to all lots of Metformin Hydrochloride Extended-Release Tablets in the US. Apotex stopped selling this product in the US in February 2019, and there remains only limited product on the market. To date, Apotex has not received any reports of adverse events related to use of the product.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Metformin Hydrochloride Extended-Release Tablets, USP is a prescription oral product indicated as an adjunct to diet and exercise to improve blood sugar control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. The affected Metformin Hydrochloride Extended-Release Tablets, USP can be identified by NDC numbers stated on the product label.

Product Strength Pack Size NDC Number
Metformin Hydrochloride Extended-Release Tablets, USP 500mg 100's Bottle 60505-0260-1

The affected Metformin Hydrochloride Extended-Release Tablets were distributed nationwide in the USA to Warehousing Chains. Apotex Corp. is in a process of notifying its affected direct account Wholesaler, Distributor, Chain Distribution and Warehousing Chains via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product.

Wholesalers, Distributors and Retailers should return the recalled product to the place of purchase. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Customers who purchased the impacted product directly from Apotex can call Inmar Rx Solutions at 1-888-985-9014 (option 1) (9:00am – 5:00-pm, EST Monday thru Friday), to arrange for their return.

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. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP 500 mg and 750 mg Due to Detection of N-Nitrosodimethylamine (NDMA)

Jun 5, 2020

Audience: Consumer, Health Professional, Pharmacy

June 05, 2020 -- Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI).

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. The lots being recalled are packaged under the Actavis Pharma, Inc. label and are contained in the table below. They were distributed nationwide in the USA as retail bottles of 100 tablets and 1000 tablets to Teva’s direct customers between January 8, 2019 and May 27, 2020.

The affected Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, being recalled are described as:

  • Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, white to off-white capsule shaped tablets, debossed with an Andrx logo with “571”on one side and “500” on the opposite side.
  • Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, light yellow capsule shaped tablets, debossed with an Andrx logo with “577” on one side and “750” on the opposite side.
NDC Product Description Lot Number Expiration
62037-571-01 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count 1329548A 06/2020
62037-571-01 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count 1338302M 10/2020
62037-571-01 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count 1348968M 10/2020
62037-571-01 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count 1348969M 11/2020
62037-571-01 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count 1348970M 10/2020
62037-571-01 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count 1376339M 09/2021
62037-571-10 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count 1323460M 06/2020
62037-571-10 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count 1330919M 06/2020
62037-571-10 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count 1338300A 10/2020
62037-571-10 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count 1341135M 12/2020
62037-571-10 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count 1391828M 11/2021
62037-577-01 Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count 1333338M 08/2020
62037-577-01 Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count 1333339A 08/2020
62037-577-10 Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 1000 Count 1354471A 02/2021

Teva is notifying its distributors and customers affected by this recall via FedEx overnight mailing. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US Food & Drug Administration, It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals. Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin.

Customers and patients 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.

Patients wishing to return product may contact Teva’s product recall processor to obtain instructions and a return kit for returning their medication:

  • Contact Inmar at 1-855-532-1850 (Hours of Operation: 9 am to 5 pm Eastern Time, Monday – Friday) or email Inmar at: tevarecalls@inmar.com.
  • Inmar will provide the materials needed to return their medication and instructions for reimbursement.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Patient safety and product quality are critical to Teva. Teva will continue to partner with, and regularly update, all relevant regulatory authorities as relevant information becomes available.

Source: FDA

Marksans Pharma Limited Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)

Jun 5, 2020

Audience: Consumer, Health Professional, Pharmacy

June 05, 2020 -- Marksans Pharma Limited, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96ng/day.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables. Marksans Pharma Limited has not received any reports of adverse events related to this recall to date.

Metformin Hydrochloride Extended-Release Tablets, USP 500mg is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in 100 count bottles with NDC code 49483-623-01. The affected Metformin Hydrochloride Extended-Release Tablets, USP 500mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘101’ on one side and plain on the other side.

Product name: Metformin Hydrochloride Extended Release Tablets USP, 500 mg

Lot #: XP9004

Expiry Date (MM/YYYY): 12/2020

The product can be identified by lot # XP9004 and expiration date 12/2020. Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 was distributed by Time-Cap Labs, Inc. (located at 7 Michael Avenue, Farmingdale, New York 11735) nationwide in the USA to wholesalers who further distributed to pharmacies.

Marksans Pharma Limited is notifying its distributors and customers by issuing notification letter and press release and is arranging for return/replacement etc. of recalled product lot. Distributors/retailers that have Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 which is being recalled should return to place of purchase.

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.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 or call Time-Cap Labs, Inc. at 1-877-376-4271 or Fax at 631-753-2220

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, Due to Detection of N-Nitrosodimethylamine (NDMA) Impurity

Jun 1, 2020

Audience: Consumer, Health Professional, Pharmacy

June 01, 2020 -- Amneal Pharmaceuticals LLC Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Retail Level.

Amneal was notified by the U.S. FDA that the Agency’s testing of seven lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, showed N-Nitrosodimethylamine (NDMA) amounts above acceptable FDA levels. FDA recommended the recall of the seven tested lots. Amneal has agreed to this recall and has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, out of an abundance of caution. Further scientific evaluations are ongoing at Amneal.

To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables.

Metformin HCl Extended Release Tablets, USP, 500 mg and 750 mg, manufactured by Amneal, are prescription, solid oral products that are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

The Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, subject to the recall, are identified by the NDC numbers stated on the product label.

Metformin HCl Extended Release Tablets, USP, 500 mg

53746-178-01 100 count bottles
53746-178-05 500 count bottles
53746-178-10 1000 count bottles
53746-178-90 90 count bottles
53746-178-Bulk Bulk Box
65162-178-09 90 count bottles
65162-178-10 100 count bottles
65162-178-11 1000 count bottles
65162-178-50 500 count bottles

Metformin HCl Extended Release Tablets, USP, 750 mg

53746-179-01 1000 count bottles
53746-179-Bulk Bulk Box
65162-179-10 100 count bottles

The affected Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, lots were distributed nationwide in the US directly to Wholesalers, Distributors, Retailers and Repackagers.

Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for return of all the recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Customers who purchased the impacted product directly from Amneal may call Amneal at 1-833-582-0812 or email to AmnealproductrecallDS@amneal.com, Monday – Friday, 8:00 am – 5:00 pm, EST, for further information.

Retailers who have Metformin Hydrochloride Extended Release Tablets, USP, 500 mg or 750 mg, which are being recalled, should cease dispensing and contact Inmar at 855-532-1851 or via email at Rxcalls@inmar.com Monday – Friday, 8:00 am – 5:00 pm, EST, to arrange for product return.

If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Amneal Drug Safety by phone at 1-877-835-5472, Monday - Friday, 8:00 am – 6:00 pm, EST, or via e-mail at DrugSafety@amneal.com.

Any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Safe Harbor Statement

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including, among other things, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy. Words such as “may,” “will,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “assume,” “continue,” and similar words are intended to identify estimates and forward-looking statements.

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Amneal Pharmaceuticals, Inc. (the “Company”). Such risks and uncertainties include, but are not limited to, risks related to the products and recall thereof described in this press release. A further list and descriptions of these risks, uncertainties and other factors can be found in the Company’s most recently filed Annual Report on Form 10-K for the fiscal year ended December 31, 2019 as supplemented by any subsequently filed Quarterly Reports on Form 10-Q. Copies of these filings are available online at www.sec.gov,www.amneal.com or on request from the Company.

Source: FDA

Metformin-containing Drugs: Drug Safety Communication - Revised Warnings for Certain Patients With Reduced Kidney Function

Apr 8, 2016

Audience: Pharmacy, Nephrology, Internal Medicine, Patient

ISSUE: FDA is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally. FDA was asked to review numerous medical studies regarding the safety of metformin use in patients with mild to moderate impairment in kidney function, and to change the measure of kidney function in the metformin drug labeling that is used to determine whether a patient can receive metformin.

FDA concluded, from the review of studies published in the medical literature, that metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function. FDA is requiring changes to the metformin labeling to reflect this new information and provide specific recommendations on the drug’s use in patients with mild to moderate kidney impairment.

FDA is also requiring manufacturers to revise the labeling to recommend that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of renal function (i.e., glomerular filtration rate estimating equation (eGFR)). This is because in addition to blood creatinine concentration, the glomerular filtration rate takes into account additional parameters that are important, such as the patient’s age, gender, race and/or weight. See the FDA Drug Safety Communication for additional information, including a data summary and a list of metformin-containing drugs.

BACKGROUND: Metformin-containing medicines are available by prescription only and are used along with diet and exercise to lower blood sugar levels in patients with type 2 diabetes. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. Metformin-containing medicines are available as single-ingredient products and also in combination with other drugs used to treat diabetes. The current drug labeling strongly recommends against metformin use in some patients whose kidneys do not work normally because use of metformin in these patients can increase the risk of developing a serious and potentially deadly condition called lactic acidosis, in which too much lactic acid builds up in the blood.

RECOMMENDATION: Healthcare professionals should follow the latest recommendations when prescribing metformin-containing medicines to patients with impaired kidney function. Patients should talk to their health care professionals if they have any questions or concerns about taking metformin.

The labeling recommendations on how and when kidney function is measured in patients receiving metformin will include the following information: 

  • Before starting metformin, obtain the patient’s eGFR.
  • Metformin is contraindicated in patients with an eGFR below 30 mL/minute/1.73 m2.
  • Starting metformin in patients with an eGFR between 30-45 mL/minute/1.73 m2 is not recommended.
  • Obtain an eGFR at least annually in all patients taking metformin. In patients at increased risk for the development of renal impairment such as the elderly, renal function should be assessed more frequently.
  • In patients taking metformin whose eGFR later falls below 45 mL/minute/1.73 m2, assess the benefits and risks of continuing treatment.  Discontinue metformin if the patient’s eGFR later falls below 30 mL/minute/1.73 m2.
  • Discontinue metformin at the time of or before an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/minute/1.73 m2; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast.  Re-evaluate eGFR 48 hours after the imaging procedure; restart metformin if renal function is stable. 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[04/08/2016 - Drug Safety Communication - FDA]
 

More metformin Resources