It's also one form of a vitamin that gets much buzz these days, with a variety of indicated treatments. Here's why national experts warn these doses aren't ideal.
According to Harvard Health Publishing, half of senior men and 40% of senior women take medication to lower their cholesterol levels—and more people not currently taking those drugs would likely stand to benefit from doing so. Yet as a newly updated national recall announcement by the U.S. Food & Drug Administration (FDA) shows, one particular type—niacin tablets manufactured by Kremers Urban Pharmaceuticals, Inc. (KUP)—has been identified as a potential threat.
Niacin, also known as nicotinic acid, is a form of vitamin B3. As the Mayo Clinic explains, it is “used by the body to turn food into energy” as well as to “keep the nervous system, digestive system, and skin healthy.” It can be taken as part of a daily multivitamin, as a supplement with potentially varying formulations, or as a prescription-only medication sold at high doses. In this last case, it is “used as a treatment to improve cholesterol numbers or correct a vitamin deficiency,” those experts note.
The drugs implicated in the recall fell into the latter category, as they were available by prescription and primarily used to lower cholesterol. According to Lannett Company, Inc., KUP’s parent company since 2015, the tablets can also be used for a range of related purposes:
- To lower high levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (APO-B), and triglycerides (TG), and to raise levels of high-density lipoprotein cholesterol (HDL-C) in people with primary high cholesterol disorders or mixed cholesterol problems.
- To lower the risk of having another non-fatal heart attack in people who have previously had a heart attack and have high cholesterol.
- To lower triglycerides in adults who have very high levels of triglycerides.
- When used together with a bile acid–binding medicine:
- To slow down or help reverse the buildup of fatty deposits in the arteries in people who have coronary artery disease and high cholesterol.
- To help lower high total cholesterol and high LDL cholesterol in adults with primary high cholesterol when used along with diet changes.
The niacin tablets were recalled due to “failed dissolution specifications,” likely meaning that the drug did not dissolve properly during testing. This could impact how the body absorbs the active ingredients, since the pills appear to have been unable to break down at the expected speed.
On November 19, the FDA updated the notice to say that the event is now considered a Class II incident. This suggests that “temporary or medically reversible consequences” are possible, but that the “probability of serious adverse health consequences is remote.”
The affected drugs were sold in 90-count bottles of 1,000-milligram (mg) extended-release tablets. They are red and oval in shape, un-scored, film-coated, and bear the imprint “KU/322.” The packaging shows the National Drug Code (NDC) 62175-0322-46. The following expiry dates and lot numbers are associated with the recall:
- Exp. Date 10/2025 – Lot Number(s): GS044385, GS044979, GS045797
- Exp. Date 12/2025 – Lot Number(s): GS046415
- Exp. Date 02/2026 – Lot Number(s): GS047197, GS047786, GS048477
- Exp. Date 03/2026 – Lot Number(s): GS049480, GS048873, GS049733, GS050224, GS050721, GS050722, GS051145, GS051726, GS052484
- Exp. Date 04/2026 – Lot Number(s): GS053612
- Exp. Date 05/2026 – Lot Number(s): GS054987, GS054409, GS055697, GS056192, GS056886, GS058077, GS057330
If you’re unsure of whether your particular prescription was affected, it’s important to consult your doctor or pharmacist for next steps.
Also, as the Mayo Clinic suggests, you may want to also take the opportunity to ensure that niacin is still your best course of treatment: “Niacin isn’t for everyone,” the health authority writes. “People who take niacin in addition to common cholesterol medicines see very little additional benefit. And niacin can cause uncomfortable and sometimes dangerous side effects.”
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