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), which is classified as a probable human carcinogen. To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.
 
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 product 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 FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.
 
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. Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions Inc. at (855) 532-1856.
 
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.