Ningde Wanxing Food Added to US FDA Import Alert! Large Yellow Croaker Involved Two Veterinary Drug Residues

In the updated Import Alert 16-124 published by the US Food and Drug Administration (FDA) on November 2, 2026, Ningde Wanxing Food Co., Ltd. of Ningde, Fujian, appears on the list of seafood companies associated with unapproved veterinary drugs. The FDA record concerning this company involves Croaker, with the problem items including two antibacterial drugs: Ciprofloxacin and Enrofloxacin.

Import Alert 16-124 is titled "Detention Without Physical Examination of Aquaculture Seafood Products Due to Unapproved Drugs." This measure targets unapproved drugs in aquaculture seafood products, and the FDA may detain relevant products from listed companies without physical examination (DWPE). When products enter the United States, importers must provide evidence of compliance with regulatory requirements in order to request release.

In the company record corresponding to Ningde Wanxing, the FDA describes the product as Croaker and explicitly lists CIPROFLOXACIN and ENROFLOXACIN as the two problem items. The public record also involves the relevant product category of aquaculture seafood. The FDA uses the English name Croaker and does not further specify the exact fish species or Latin scientific name in the company entry, so it cannot be directly limited to a particular large yellow croaker product.

Ciprofloxacin and Enrofloxacin both belong to the fluoroquinolone class of antibacterial drugs. Enrofloxacin is mainly used for the treatment of animal diseases, while Ciprofloxacin is a related antibacterial drug. The use of both drugs is strictly regulated, and whether they are approved for specific aquaculture species and whether they meet the prescribed conditions of use both affect the compliance of seafood exports.

This incident requires distinguishing among three concepts: "detection of veterinary drug residues," "residues exceeding the limit," and "use of unapproved drugs." US regulation of unapproved new animal drugs is not entirely based on a particular residue limit. Even if the detected concentration does not exceed the limit set by other countries or regions, if the relevant drug has not been approved by the United States for the corresponding animal or food use, it may still constitute an import violation.

The strict control of fluoroquinolone drugs is also related to the risk of antimicrobial resistance. Antibacterial drug residues in food may become part of antimicrobial resistance risk management, so aquaculture drug use, withdrawal period implementation, raw material traceability, and finished product testing are all important elements of seafood safety management.

It should be noted that the FDA's public import alert record does not disclose the specific detected concentrations, sampling batches, or laboratory test reports of the Ningde Wanxing-related products, nor does it state whether the two drugs were detected simultaneously in the same batch of products. Therefore, it cannot currently be written that a certain batch of large yellow croaker has been detected with both drugs exceeding the limit at the same time, nor can it be directly concluded that the products have already caused health harm to consumers.

However, this does not mean the issue is merely a general risk warning. The FDA has explicitly linked Ningde Wanxing's Croaker products to the two unapproved drug issues and has placed the company on the corresponding import alert list. For exporting companies, this means that the relevant products will face regulatory scrutiny when entering the US market, and importers also need to bear the corresponding compliance risks.

For aquaculture and processing companies, drug management cannot rely solely on factory testing. The types of drugs used on farms, procurement records, dosage, timing of use, withdrawal periods, and raw material batch traceability all need to be documented in complete records. Processing companies also need to be able to match raw material sources with aquaculture drug use information so as to provide evidence when the importing country requests a review.

Whether the FDA subsequently accepts the company's corrective materials, whether it adjusts the import alert status of the relevant companies, and whether Ningde Wanxing's related products can resume normal entry into the US market will become regulatory milestones to watch going forward.