FDA Issues Multiple Recalls for Cholesterol Drug, Male Enhancement Supplements
Multiple health product recalls have been announced, including a prescription cholesterol medication for dissolution issues and dietary supplements containing undeclared erectile dysfunction drugs Tadalafil and Sildenafil. The FDA and international regulators warn of potential health risks.
Federal health agencies have issued several recalls in recent months for health products ranging from a prescription cholesterol medication to dietary supplements containing undeclared drugs.
On May 29, the FDA reported that Golden State Medical Supply Inc. voluntarily recalled 2,961 bottles of 1,000-milligram Niacin Extended-Release tablets. The recall was due to failed dissolution specifications: during 12-month long-term stability testing, subject lots were out of specification for stage 3 dissolution at the 24-hour timepoint. Five lots with an expiration date of January 31, 2027 are affected: GS065128, GS065844, GS066695, GS067432, and GS067993. The tablets, manufactured by Kremers Urban Pharmaceuticals Inc., are used to treat high cholesterol and triglyceride levels. The FDA classified this as a Class II risk, indicating temporary or medically reversible adverse health consequences are possible.
Separately, Brooklyn-based USALESS.COM is recalling its Rhino Choco VIP 10X chocolate male enhancement supplement due to undeclared tadalafil, the active ingredient in Cialis. The 10-gram, 12-piece supplement, sold online and in retail stores with an expiration date of October 2027, may interact with nitrates and lower blood pressure to dangerous levels. Consumers are asked to return the product for a full refund. The FDA previously warned in 2018 about Rhino-branded male enhancement products.
In Australia, the Therapeutic Goods Administration announced that Natures Valley Collagen Builder tablets were found to contain 199.3 milligrams per tablet of undeclared sildenafil, a prescription-only medicine. The TGA noted that sildenafil may interact with nitrates, potentially lowering blood pressure to dangerous levels. The supply of these tablets is illegal in Australia, and in Hong Kong they are not registered as a pharmaceutical product.