Customs and Border Protection (CBP) and Food and Drug Administration (FDA) jointly seize over $3.5 million worth of counterfeit pharmaceuticals at Cincinnati port.

Customs and Border Protection (CBP) and Food and Drug Administration (FDA) jointly seize over $3.5 million worth of counterfeit pharmaceuticals at Cincinnati port.

In a significant operation, U.S. Customs and Border Protection (CBP) and the U.S. Food and Drug Administration (FDA) have jointly confiscated hundreds of boxes containing possible counterfeit and unapproved medications, valued at over $3.53 million, during a recent operation at the Port of Cincinnati.

The seized shipments, which had final destinations in 40 of the 50 states, including Washington D.C., were found to contain various medications such as Botox, Juvéderm, dermal fillers, erectile dysfunction medication, contact lenses, and other FDA-prohibited items. Counterfeit injectables of Ozempic, Semaglutide, Retatrutide, and Tirzepatide were also discovered.

The FDA, responsible for ensuring the safety and efficacy of all drugs marketed in the United States, provides guidance on how human drugs can be legitimately imported into the country. Any FDA-regulated drug product offered for import must comply with the same safety, labeling, and quality standards as domestically marketed drugs. The FDA inspects and reviews all drug imports to determine admissibility, refusing entry to products that violate these regulations.

Importers are advised to be knowledgeable about their products and suppliers and to work with customs brokers to submit valid data, supporting the FDA’s ability to review and approve legitimate drug imports efficiently. Importers must provide accurate, complete data to facilitate this review process.

The FDA’s focus on drug safety and integrity in foreign supply chains is evident in the strict regulatory requirements for drug imports through state programs, such as the State Importation Programs (SIPs) for Canadian drugs. These programs exclude biologics, controlled substances, and certain injectables.

CBP, another key partner agency in enforcing laws related to the drug supply, targets and inspects questionable shipments being imported into the U.S. and takes enforcement action when necessary. Consumers are recommended to purchase pharmaceuticals from reputable sources and ensure they are administered by properly trained and licensed medical professionals.

The health risks of illicit products are concerning due to the unknown ingredients, which may not be safe when purchased from unapproved sources online. For instance, Ozempic, an FDA-approved medication for the treatment of type 2 diabetes, is not FDA-approved for the treatment of weight loss.

The combined value of all seized counterfeit products would have been over $3.53 million if they were legitimate. A total of 54,843 counterfeit products and 16,740 injectables of counterfeit pre-filled medicated pens were seized during the operation.

The operation between U.S. Customs and Border Protection (CBP) and U.S. Food and Drug Administration took place at the Port of Cincinnati. The seized shipments originated from many different countries, with the most coming from Hong Kong, China, Colombia, and Korea.

CBP works closely with the FDA to protect the nation's drug supply. The FDA centralized import reviews nationwide through the Nationalized Entry Review Program (NER) since August 2025, which enables coordinated, faster, and more efficient screening of imported products to protect against unsafe or counterfeit drugs. The FDA also works closely with U.S. Customs and Border Protection (CBP) to enforce laws at entry points, with CBP seizing counterfeit or unapproved drugs and encouraging consumers to only purchase pharmaceuticals from reputable sources.

In summary, legitimate importation of human drugs is governed by adherence to FDA’s regulatory standards—ensuring safety, efficacy, proper labeling, and authenticity—and rigorous entry review coordinated with CBP enforcement. Unauthorized, counterfeit, or unsafe drug imports are subject to refusal, seizure, and penalties.

1. The government agency responsible for ensuring the safety and efficacy of drugs marketed in the United States, the Food and Drug Administration (FDA), is actively collaborating with U.S. Customs and Border Protection (CBP) to combat counterfeit medications and unapproved items, particularly at the Port of Cincinnati.
2. In a health-and-wellness-related concern, the Operation at the Port of Cincinnati had a significant impetus when CBP and FDA discovered numerous questionable shipments containing various drugs and medical supplies, including counterfeit injectables of Ozempic, Semaglutide, Retatrutide, and Tirzepatide.
3. Further investigations into general-news and crime-and-justice matters reveal that the seized counterfeit products, originating from various countries such as Hong Kong, China, Colombia, and Korea, were destined for 40 states, illustrating the extent of this unlawful trade reaching a total worth of over $3.53 million.

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