RECALL: More Than 100 Drug Products Recalled Due to Microbial Contamination

The FDA is warning consumers, including pet owners, not to use drug products, including homeopathic drug products, made by the North Carolina—based King Bio Inc. The products, including those labeled as Dr. King’s, may pose a safety risk to people and pets due to high levels of microbial contamination identified at the manufacturing site.

Yesterday, King Bio expanded its voluntary recall for a second time to include all of its water-based products for human and animal use. The pet products included in the recall—sold to both consumers and veterinary professionals—are marketed for a variety of uses, including urinary incontinence, anxiety, arthritis, and digestion relief (view the complete list here). The FDA recommends that consumers stop using and dispose of these products immediately.

Consumers and pets who ingest these products may be at increased risk for serious infection, potentially requiring medical attention, due to high levels of microbial contamination. During an FDA investigation of the King Bio facility, several microbial contaminants were found in products, including Burkholderia multivorans, which is a member of the Burkholderia cepacia complex that can cause illness in people with compromised immune systems. Additionally, evidence collected during the FDA’s inspection indicated recurring microbial contamination associated with the water system used to manufacture drug products.

“We take product quality issues seriously, and when we see substandard conditions during the course of our inspections—in this case, conditions that are leading to high levels of microbial contamination with the potential to harm the public—we act swiftly to try to ensure the products are removed from circulation,” said FDA Commissioner Scott Gottlieb, MD. “In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer.

In addition to our concerns with contamination, some homeopathic products may not deliver any benefit and have the potential to cause harm. That’s why we’ve taken steps in the last year to advance a new regulatory approach to prioritize additional enforcement and regulatory actions against certain homeopathic products. We’re focused on products that have the greatest potential to cause risk to patients, including products for vulnerable populations like children. In the past year, we’ve also taken actions against [manufacturers of] homeopathic products that were making unproven drug claims.”

Consumers and pet owners who have purchased these products should contact their health care professional or veterinarian if they have concerns or observe signs of an infection after use of these products. The FDA also encourages medical professionals and consumers to report adverse events or quality problems experienced with the use of King Bio’s products to the FDA’s MedWatch Adverse Event Reporting program.