More than a dozen recalls have been issued for the diabetes drug metformin ER due to high levels of a toxic cancer-causing chemical called NDMA.
Riomet Recalled for NDMA
In September 2020, Sun Pharma recalled Riomet ER® (metformin) due to NDMA contamination. Riomet ER is a liquid that comes in a 16-oz. round bottle. The recall involves Riomet ER (500 mg per 5 mL), Lot #AB06381 and Expiration Date: 10/2021.
List of Metformin Recalls for NDMA Carcinogens
January 25, 2021 — Nostrum Laboratories expanded a recall for metformin ER recall yet again after finding high levels of NDMA in Metformin ER, USP 750 mg (generic equivalent to Glucophage®) with Lot MET200601 and an Expiration Date: 07/2022.
January 4, 2021 — Nostrum Laboratories expanded a metformin recall from November 2 to include Lot #MET200501 of metformin (generic Glucophage®) due to high levels of NDMA. The recall involves Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets), which can be identified as off-white oblong tablets debossed with “NM7.”
November 2, 2020 — Nostrum Laboratories recalled Metformin Extended Release Tablets (750-mg) after tests found high levels of NDMA carcinogens. The recall involves 2 lots (MET200101 and MET200301) with expiration dates of 05/2022 in bottles of 100 tablets.
October 2, 2020 — Marksans Pharma Ltd. has dramatically expanded a metformin recall due to the toxic NDMA carcinogen. The recall incluces 76 lots of extended-release metformin (Metformin ER), including both 500-mg and 700-mg dosage strengths. It was distributed by Time-Cap Labs Inc. in 90-, 100-, 500-, or 1000-count pill bottles.
July 8, 2020 — Bayshore Pharmaceuticals of New Jersey recalled one lot of 500-mg and one lot of 750-mg Metformin Extended-Release after the FDA tested samples and discovered high levels of NDMA.
July 8, 2020 — Lupin Pharmaceuticals recalled all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg due to NDMA. The metformin were distributed from November 2018 to May 2020.
July 3, 2020 —Granules Pharmaceuticals recalled 12 lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 after one lot tested positive for high levels of NDMA.
June 11, 2020 — Lupin Pharmaceuticals, Inc. recalled one lot of Metformin Hydrochloride Extended-Release Tablets (generic equivalent of Fortamet®), 500mg, Lot G901203 due to unsafe levels of NDMA.
June 5, 2020 — Marksans Pharma Ltd, India recalled Metformin ER (500-mg) — Lot# XP9004 — in 100 count bottles with NDC code 49483-623-01 and expiration date 12/2020. It was distributed by Time-Cap Labs, Inc.
June 5, 2020 — Teva Pharmaceuticals recalled 14 lots of Metformin Extended-Release (500-mg and 750-mg) due to high levels of NDMA. They were distributed from January 8, 2019 to May 27, 2020.
May 29, 2020 — Amneal Pharmaceuticals recalled all lots of Metformin Extended-Release (500-mg and 750-mg) due to unsafe levels of a carcinogenic chemical called NDMA.
May 27, 2020 — Apotex Corp. recalled all lots of Metformin Extended-Release (USP 500mg / 100-count bottles / NDC Number 60505-0260-1). The recalled metformin contained unsafe levels of the cancer-causing chemical NDMA (N-Nitrosodimethylamine). Apotex stopped selling it in the U.S. in February 2019.
FDA Tests Find ‘Unacceptable’ Levels of NDMA in Metformin
In May 2020, tests by the FDA found high levels of NDMA carcinogens in several batches of extended-release metformin, according to Bloomberg.
The FDA said its tests on immediate-release metformin did not find high levels of NDMA.
The FDA contacted several unnamed drug-makers to take “quick and appropriate action,” which may include recalls — and potentially, lawsuits from people with cancer.
The announcement is a major reversal for the FDA, which previously said in February that their initial tests did not find dangerous levels of NDMA in metformin.
Pharmacy Finds High Levels of NDMA, Demands Metformin Recalls
In March 2020, the online pharmacy Valisure petitioned the FDA to recall metformin after 16 batches made by 11 companies tested positive for high levels of a cancer-causing chemical called NDMA.
Valisure warned that many batches of metformin had over 10X the FDA’s daily intake limit for NDMA, and one batch of metformin made Amneal Pharmaceuticals LLC had 16.5X the daily limit of NDMA.
FDA’s Tests Found No NDMA in Metformin, Valisure’s Did — Who Is Right?
Valisure’s tests found highly-variable levels of NDMA from batch to batch, even from the same company, which may help explain why the FDA’s tests found no NDMA or only extremely low levels.
Valisure said it is not clear why their tests found high levels of NDMA in metformin, when the FDA did not. Valisure said it used a more accurate testing method than the FDA. Valisure also tested more batches. Valisure tested 38 batches of metformin made by 22 companies, and 42% tested positive for high levels of NDMA. The FDA only tested 16 batches of metformin from 7 drug-makers.
FDA Metformin Tests Find No NDMA or Very Low Levels
On February 3, 2020, the FDA issued a statement after laboratory tests on metformin detected extremely low levels of n-nitrosodimethylamine (NDMA), or no NDMA was detected at all: “To date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA. FDA has not recommended metformin recalls in the U.S.”
What is the problem?
Health agencies in the U.S., Canada and Europe are investigating whether the type-2 diabetes drug metformin contains the same cancer-causing chemical that led to global recalls for blood pressure drugs (valsartan) and heartburn medications (Zantac) in early 2019.
Metformin May Be Contaminated With Cancer-Causing Toxin
In December 2019, the FDA opened an investigation into possible NDMA contamination in metformin sold in the U.S., after recalls were issued in other countries, and similar investigations were launched in Europe.
If tests on metformin in the U.S. find NDMA above the acceptable daily limit of 96 micrograms, the FDA said it will recommend recalls.
What is NDMA?
N-Nitrosodimethylamine (NDMA) and similar chemicals, collectively called nitrosamines, are known carcinogens (cancer-causing substances). Everyone is exposed to some level of NDMA because it is commonly found in water and foods like grilled meat, dairy products, and vegetables.
List of Cancers Linked to NDMA
- Liver cancer
- Kidney cancer
- Intestinal cancer
- Stomach cancer
- Pancreatic cancer
- Colon cancer
- Esophageal cancer
- Ovarian cancer
- Testicular cancer
- Bladder cancer
- And more
Metformin has not been recalled in the U.S. yet, but Valisure petitioned the FDA to issue recalls in February 2020. Certain batches of metformin have been recalled in Singapore and Canada.
In December 2019, Singapore recalled 3 batches of metformin after finding unacceptable levels of NDMA.
In February 2020, Canada issued multiple recalls for metformin after tests found high levels of NDMA: On February 24, six batches of metformin were recalled by Ranbaxy Pharmaceuticals. On February 5, eight batches of Metformin-ER (extended release) 500-mg tablets were recalled by Apotex Inc.
What is Metformin?
Metformin is the 4th most commonly prescribed drug in the U.S., with 80 million prescriptions written in 2019 alone. It is used to help people with type-2 diabetes control their blood-sugar levels. Metformin is a generic drug that is also sold under the names Fortamet, Glucophage, Glumetza, and Riomet.