Infla-650 Herbal Dietary Supplements are being recalled because they contain three drugs that are not listed on the product label. The drugs are acetaminophen, diclofenac, and phenylbutazone. Any item that contains these products cannot be marketed as a dietary supplement. And the presence of these compounds means that the product is considered an unapproved drug … Read more
Dietary supplement Schwinnng Capsules is being recalled because it contains Nortadalafil, an active drug ingredient. This means that the herbal supplement is an unapproved new drug for which safety and efficacy have not been established. No adverse events have been reported to the company to date in connection with this issue. The recalling firm is … Read more
Botanical-Be is recalling all lots of three dietary supplements because they contain undeclared Diclofenac, which is an approved non-steroidal anti-inflammatory drug. The presence of this drug in the supplements Kuka Flex Forte, Artri King, and Reumo Flex renders them unapproved drugs for which safety and efficacy have not been established. The firm has not received … Read more
The FDA is warning consumers about the dangers of Tianeptine, an unapproved drug that is “linked to serious harm, overdoses, and death,” according to the government. Some companies are illegally marketing and selling products containing tianeptine to consumers. Those companies are also making what the FDA calls dangerous and unproven claims that tianeptine can “improve … Read more
A New Jersey supplement company owner pleads guilty to introducing an unapproved new drug into interstate commerce “with the intent to defraud and mislead the U.S. Food and Drug Administration (FDA) and consumers,” according to a news release from the U.S. Department of Justice. The owner is Nicholas Andrew Puccio. The government alleges that from 2016 … Read more
Dash Exclusive is voluntarily recalling all lots of Imperia Elita Vitaccino Coffee because it contains sibutramine and fluoxetine, two drugs that are not declared on the label. This product is a weight loss and anxiety dietary supplement. FDA analysis found the presence of these compounds in the product. The company has not received any reports of … Read more
The FDA has issued warning letters to two companies selling OTC CBD products for pain relief. The items are labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The letters address the illegal marketing of unapproved drugs labeled as containing CBD. The FDA has not approved … Read more
Sundial Herbal Products are being recalled for unapproved drugs to be in compliance with FDA Drug Regulations. These recalled products are misbranded because they have labeling claims that could result in delay of appropriate treatment by a healthcare provider. Because these dietary supplements are unapproved, their safety and efficacy have not been established. No illnesses … Read more
Herbal Doctor Remedies is voluntarily recalling all drug products within expiration dates to the consumer level. These products were marketed without FDA approval and were manufactured outside controls required by current Good Manufacturing Practices. This could result in risk to consumers, since they are marketed with uses that are not amenable to self-diagnosis. And, lack … Read more
Happy Together, a company in Boynton Beach, Florida, is recalling all lots of Rhino 5K capsules because they are tainted with sildenafil and Tadalafil. Sildenafil and Tadalafil are FDA approved drugs that are available only through prescription. Those drugs render the product as a whole an unapproved drug for which efficacy and safety has not … Read more