Taking a pill every morning at the same time, in the same amount, and from the same little orange bottle might not contain what it says it does. This thought is slightly unsettling. It was pretty much the same thing the FDA said in July when it ordered the recall of levothyroxine sodium tablets across the country because they were not stable enough.
Not powerful. A fancy word for something simple: the tablet you’re holding has less active drug in it than the label says. That is not a small thing for the millions of Americans who take levothyroxine every day to treat hypothyroidism or thyroid cancer.
Twelve different products with seven different dose strengths (25 to 150 micrograms) are being recalled. The tablets were made by Lupin Pharmaceuticals, and they were distributed by Major Pharmaceuticals and Cardinal Health. The lots that were damaged began shipping in January 2025, and some of them won’t go bad until early 2027. That window is big. It’s possible that many patients who got the tainted medicine and had it refilled more than once didn’t notice anything. This is both good news and, in a strange way, part of the problem.
The FDA puts a product in Class II, which is the middle of its risk categories. It means that the product might cause short-term or fixable health issues, but probably won’t do any real damage. Most people who were taking levothyroxine probably didn’t have any major side effects from a slightly lower dose. But some people could tell the difference, and they didn’t know why. Putting on weight that wasn’t there before. Not normal tiredness. There was more hair coming out of the brush than usual. If you don’t pay attention to these signs, you might think that your thyroid isn’t working properly. It’s easy to do that because you’re stressed, tired, or old.
Family doctor Dr. David Cutler at Providence Saint John’s Health Center in Santa Monica made it clear. If someone took a subpotent tablet and their thyroid hormone levels dropped because of it, they might gain weight, have trouble going to the bathroom, feel tired, and lose their hair. According to him, there isn’t much chance of long-term damage because doctors check the blood of thyroid patients every three to six months and would notice a change in hormones before it got worse. That gives me comfort. But it’s important to remember that not all people with thyroid problems go to the doctor when they’re supposed to.
Patients are really upset about this recall because most pharmacies pour tablets into their own dispensing vials. Before the bottle gets to your medicine cabinet, the NDC code, the manufacturer’s lot number, and the original packaging are all gone. That’s why the FDA didn’t tell pharmacies to get in touch with patients directly. The recall works at the distribution level, which means that shelves are cleared, but the person who has been taking these tablets every day is mostly on their own to figure it out. A few state boards of pharmacy stepped up. On July 15, California’s Board of Pharmacy sent out a notice asking all pharmacies in the state to look over their own recall procedures. That kind of initiative is important. It’s still not clear if every state did the same.
That being said, the way forward is pretty clear. Phone the drug store where the prescription was last filled. Ask for the lot number, manufacturer name, and NDC number of the most recent supply that was given out. Look at it next to the recall list. If you’re still not sure, ask your doctor to do a simple blood test for your thyroid. Cutler said that a number on a lab report is the clearest sign of safety right now.
Levothyroxine has had problems with potency in the past. Between 1990 and 1997, the FDA recorded ten separate recalls for subpotency and other problems. Because of this, the agency officially called levothyroxine sodium a “new drug” in 1997. This meant that companies that made it had to get official approval and follow stricter rules. Things got better. They did not get better.
As recently as June 2025, Accord Healthcare called back more than 82,000 bottles of 25 mcg levothyroxine tablets for the same reason: they were not working properly, which is also a Class II problem. You should pay attention to the pattern.
It sounds like Cutler was right when he said that the fact that this problem was found during regular stability tests shows that the monitoring system works. Someone ran an assay somewhere in a lab, found that the numbers were wrong, and called for a recall. That’s how the process works. But there is a gap between the system working and patients knowing about it. In that gap, real people wonder if the medicine they have been taking has been working as it should because of how small it may seem on paper.
