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Drug Labels Inadequate for Metformin Drug Recalls

No one wants to consume carcinogens in food or water and certainly not in medicine. The FDA just announced metformin drug recalls due to contamination.
Drug Labels Inadequate for Metformin Drug Recalls
Recall stamp illustration isolated on white background.

In case you might have missed our alerts about metformin drug recalls, here is a link to this latest drug debacle. Yup, the FDA has been caught up in another nitrosamine contamination scandal. Five companies were identified: Actavis, Amneal, Apotex, Lupin and Marksans. Now, one of the world’s largest generic manufacturers, Teva, has also become involved in the metformin drug recalls.

The company announces it 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.”

You can find the Teva NDC (National Drug Code) numbers and Lot Numbers at this link

The Dirty Little Secret About Drug Labels:

Just because the generic drug companies provide the FDA with a list of the lot numbers or NDC numbers that are involved in the metformin drug recalls does not mean you will know if your pills have been affected. Here is a question from a reader of our syndicated newspaper column:

Q. I have just read that the FDA will be asking some drug companies to recall metformin. How can I tell if my diabetes medication is being recalled? My pill bottle does not list the manufacturer anywhere on the label. How can we as patients know if our medicine is safe or not?

A. You have discovered one of the weakest links in the drug supply chain. Pharmacies do not have to put lot numbers on the label of the amber pill bottles they dispense. It may also be hard to find the NDC number.

As a result, it can be very challenging to determine if a particular medication has been recalled unless the pharmacy contacts the patient directly. That often comes from the corporate office and can take weeks or months after a recall.

In the case of metformin, the FDA recently announced that some extended-release formulations had unacceptably high levels of the probable carcinogen NDMA. You should not stop taking your metformin suddenly, but you can ask your pharmacist to verify that your formulation is not contaminated with NDMA. If it is, request a refill with a product that has been tested and found to be safe.

More Comments About Metformin Drug Recalls:

Paul had to do some digging to find out if his diabetes medicine was part of the metformin drug recalls:

“When I contacted my Walmart pharmacist he said that my doctor did indeed need to prescribe a replacement for my extended release metformin due to possible tainted formulations that I had been dispensed. I don’t know how long it would have been unnoticed by my pharmacist, or doctor, if I hadn’t brought it to their attention, thanks to you.”

Grace had some challenges finding the NDC number:

“I live in Texas and get drugs under a PPO Medicare Advantage plan. The drug store we use is not putting NDC numbers on the prescription label. They are listing the manufacturer.

“You have to call to get the NDC number. They hemmed and hawed when I asked about their responsibility to provide the NDC. They stated their system was not set up this way.”

Sherry shares this concern about the metformin drug recalls:

“I am sure that more companies and more lots of metformin will turn out to have been tainted. My husband has been on the Amneal “brand” for years. The last time it was reordered, CVS had a problem getting it. Last year they changed his metformin to another manufacturer and he got sick from that one, so we had to find the Amneal. I knew that something was going on and the other day I got your email about metformin drug recalls. Amneal was on the list.

“A few years ago after a kidney stone wouldn’t drop by itself, my husband had to go in for a procedure. Luckily they caught a small bladder cancer in time. I wonder if the bladder cancer has anything to do with the metformin ingredients as they have no idea when it became tainted.”

The FDA’s Recall Catch-22 

We have written about the FDA’s disappointing system for alerting physicians, pharmacists and patients to drug recalls. It is equally disastrous if someone wants to notify the FDA of a drug quality problem.

The agency asks for the drug expiration date, NDC number and lot number on its 3500 form. But we challenge you to find that information on your prescription drug label. You can read all about this bizarre non-system at this link:

Why Is Your Prescription Drug Label A Disaster?
Have you ever looked for a lot number on a prescription drug label? It’s important if drugs are recalled. It’s impossible to find if pills are repackaged

Learn more about ways to manage blood sugar elevations in our eGuide to Preventing and Treating Diabetes. This electronic resource is available in the Health eGuide section of the website.

Share your own thoughts about the metformin drug recalls in the comment section below. If you found this article of interest, please share it with a friend who may be taking metformin. 

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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