Diabetes Medication Recall 2020: More Metformin Drugs Recalled Over Cancer Concerns

Following several recalls issued for the diabetes drug Metformin over high levels of the cancer-causing ingredient Nitrosodimethylamine (NDMA), Granules Pharmaceuticals issued a recall for 12 lots of Metformin Hydrochloride Extended-Release tablets because they may contain NDMA, as well, at levels higher than are allowable by the U.S. Food and Drug Administration.

The recalled diabetes medication was sold in 750 mg dosages and packaged in 100- and 500-count bottles. The recalled Metformin was distributed nationwide to distributors and retailers.

The medication affected by the recall carries the NDC No. 70010-492-01 in the 100-count bottles with lot and expiration dates of 4920003A/May-21, 4920004A/Jun-21, 4920005A/Jun-21, 4920009A/Nov-21, 4920010A/May-22, 4920011A/Jun-22, 4920012A/Jun-22, 4920013A/Jul-22, 4920014A/Jul-22, 4920015A/Aug-22, and 4920016A/Jan-23.

In the 500-count bottles, the recalled Metformin carries the NDC No. of 70010-492-05 with a lot and expiration date of 4920005B/Jun-21.

The drug is designed to improve blood sugar levels in adults with Type 2 diabetes mellitus. Labels of the recalled Metformin can be viewed here.

Consumers with questions about the recall or for information about returning the affected medication can contact Inmar Pharmaceutical Services for instructions and a return kit at 1-888-985-9117, Monday through Friday, 9 a.m.-5 p.m. EDT, or by email at rxrecalls@inmar.com. Inmar will provide details on how to receive reimbursement for medication.

Adverse reactions from the recalled Metformin can be reported to Granules Drug Safety at 1-877-770-3183, Monday through Friday, 8 a.m.-8 p.m. EDT, or by email at drugs.safety@granulesindia.com.

Granules recalled the medication “out of an abundance of caution” after the FDA found unacceptable levels of NDMA in one of 12 batches gthat were distributed to the U.S. market.

No other batches of the drug are affected by the recall, including Metformin Hydrochloride Immediate-Release tablets in 500 mg, 850 mg and 1,000 mg dosages, and Metformin Hydrochloride Extended-Release tablets in 500 mg dosages.

The company said it had not received any reports of adverse reactions from the recall.