Surprising FDA recalls of 2020

COVID-19 may have derailed most aspects of everyday life, but it did little to deter the FDA in 2020. This year, the FDA’s Center for Drug Evaluation and Research (CDER) was busy determining the safety and efficacy of new and existing pharmaceuticals and over-the-counter products.

In total, the FDA approved 48 novel drugs in 2020. For this article, let’s focus on the products that the FDA pulled from the market. As of this writing, that happened 318 times. The reasoning behind the recalls ranged from dissolution test failures, to cross-contamination, to exceeding acceptable intake limits of certain substances. You can see the complete list of recalls and the reasoning behind them here.

There were a number of recalls, however, that stood out during the coronavirus pandemic. One in particular was a direct result of bad actors attempting to profit from a national tragedy. Another surprising recall included an everyday, over-the-counter med that many take without a second thought. Here are three notable recalls of 2020.

Extended-release metformin

In November, the FDA announced that Nostrum Laboratories was voluntarily recalling four lots of extended-release metformin, considered a first-line treatment for diabetes, because it may have contained N-nitrosodimethylamine (NDMA) above the acceptable intake limit. NDMA has attracted wide attention as being a known carcinogen in laboratory animal tests. The FDA has not shown NDMA in immediate-release metformin products—the most commonly prescribed type of metformin.

The FDA reported in a May news release that it initially became aware of NDMA contamination in some foreign-manufactured metformin in late 2019. The discovery sparked an investigation of the US metformin supply, which concluded in February. It revealed “very low levels” in some samples, prompting the FDA to promise ongoing testing and swift action if “NDMA or other impurities were identified.”

The findings prompted voluntary recalls by companies including: Nostrum Laboratories, as well as Marksans Pharma, Sun Pharmaceutical Industries, Bayshore Pharmaceuticals, Apotex, Amneal, Lupin, and Teva.

Antacids

In January, the FDA announced voluntary recalls of prescription forms of ranitidine by Appco Pharma and Northwind Pharmaceuticals, two generic drug companies. The agency also reported that Mylan Pharmaceuticals recalled three lots of nizatidine, a similar drug. The culprit behind the recall was the same as above—unacceptable levels of NDMA. These three voluntary recalls brought the total of antacid recalls to 14 in the five months preceding the announcement—a pretty scary proposition for the more than 15 million Americans who take ranitidine at prescription levels and the millions more who regularly take lower-dose, over-the-counter versions. 

This month, the FDA announced that it is asking manufacturers to conduct their own NDMA testing measures, as well as supply samples to the FDA for additional testing. The expansion covers ranitidine and nizatidine products. The FDA now requires all manufacturers to report and refrain from distributing any lot that shows NDMA levels above the acceptable daily intake limit of 96 ng per day.

To date, the FDA has not found NDMA in other antacid treatments, such as omeprazole (Prilosec), lansoprazole (Prevacid), esomeprazole (Nexium), cimetidine (Tagamet), or famotidine (Pepcid).

Hand sanitizer

To capitalize on skyrocketing demand for hand sanitizer, some dubious players began stocking store shelves with cheap, unproven, and even dangerous hand sanitizer-like products. The FDA has officially warned against 215 of these products, especially those that contain methanol, which can cause nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, and even death.

The FDA reports that some hand sanitizers were contaminated by microbials. Others were subpotent, containing “less than the required amount of ethyl alcohol, isopropyl alcohol, or benzalkonium chloride.” Other products may have been manufactured in a facility making products that contained methanol or 1-propanol.

The FDA issued a news release in late August warning consumers about hand sanitizer that manufacturers had “packaged in containers that may appear as food or drinks,” putting consumers at serious risk if they intentionally or mistakenly ingested the products. The FDA reported incidences of hand sanitizer being sold in beer cans, children’s food pouches, as well as water, juice, and vodka bottles.

Final thought

FDA oversight isn’t confined to pharmaceuticals. The regulatory body also covers animal health products, biologics, medical devices, and even cosmetics. That’s a lot of scientific ground to cover—even under normal circumstances, when there isn't a pandemic. As we move into 2021, physicians can likely expect to see an increase in FDA activity as new COVID-19 vaccines earn emergency approval, and the ever-expanding medical device market continues its growth.