How FDA import alerts stop drugs at the border

On Oct. 27, 2026, FDA republished Import Alert 66-40, the notice it uses to stop drugs made at foreign plants that fail US manufacturing rules. When GxRadar counted the alert's Red List⁷ on Nov. 3, it named 472 firm entries in 55 countries and areas. China accounted for 160 of them and India for 111.

Entries on that list have one thing in common. Their shipments can be held at the US border without anyone from FDA opening a box or testing a sample. FDA calls this detention without physical examination, or DWPE, and the import alert is the public document that sets it in motion.

Much of the medicine sold in the US is made abroad. In fiscal 2024, 59 percent of the 4,619 manufacturing sites in FDA's drug site catalog were outside the country, and FDA conducted 972 drug quality inspections (more in FDA drug inspections by the numbers), according to the agency's Report on the State of Pharmaceutical Quality for that year¹¹. With far more plants than inspections, the border serves as a second line of enforcement.

Detention without examination

The legal basis is section 801(a) of the Food, Drug, and Cosmetic Act. It lets FDA refuse entry to products that appear to violate the law, a test FDA's import alerts page¹ calls the "appearance standard." Appearance can come from a lab result, but it can also come from a plant's inspection history or other information.

FDA first used DWPE in 1974, according to chapter 9 of its Regulatory Procedures Manual⁴, the internal rulebook for field staff. The manual is blunt about the purpose. DWPE "has the effect of reminding the importing community that FDA is a regulatory agency, not a quality control laboratory," and it "properly places the responsibility for ensuring compliance with the law on the importer."

A detained shipment is not automatically destroyed. The importer can present evidence that the goods do not have the violation listed in the alert, and each alert's "Guidance" section says what kind of evidence FDA will consider. If the evidence falls short, the shipment is refused. The manual says refused articles must be exported or destroyed under customs supervision within 90 days.

Red, yellow and green lists

Each import alert names the products and firms it covers through lists. FDA's industry FAQ on import alerts² defines them this way.

Most drug alerts work through a Red List of named firms. A few run the other way. Import Alert 62-08⁸ covers alcohol-based hand sanitizers made in Mexico as a whole country (the recalls behind it are in The methanol hand sanitizer recalls of 2020 and 2021), and only firms on its Green List are exempt. FDA's stated reason was testing data. From April through December 2020, the agency collected 112 samples of hand sanitizer from 53 Mexican manufacturers and found 94 of them, or 84 percent, violative, most because of methanol or 1-propanol.

In most cases, the FAQ says, publication on the alert itself serves as notice to the firm.

How many drug import alerts there are

On Nov. 3, 2026, FDA's list of import alerts by number⁵ listed about 150 alerts across foods, devices, cosmetics, tobacco and drugs. The agency's index for the Human and Animal Drugs industry⁶ tied 37 of them to drug products, including broad alerts that also cover foods or devices. Ten carry numbers in the 66 series, the industry code FDA uses for human and animal drugs. GxRadar opened each drug-specific alert and counted the firm entries on its Red List.

Counts are firm entries as posted on FDA's alert pages on Nov. 3, 2026; GxRadar did not merge entries that may belong to the same company. The heparin alert dates to the contamination crisis covered in our piece on the 2008 heparin contamination. Alert 66-76 enforces the fee rules described in our GDUFA explainer.

The newest drug alert, 66-80¹⁰, covers bulk active ingredients for GLP-1 receptor agonists. FDA wrote that shortages of approved GLP-1 products "led to increased compounding of such products using active pharmaceutical ingredients (APIs) from foreign sources," a history traced in our GLP-1 shortage explainer. Unlike 66-40, it works from a Green List of suppliers that have met FDA's criteria.

How a plant lands on 66-40

Import Alert 66-40 is the one most tied to manufacturing quality. Its text says DWPE may be appropriate when an FDA inspection, a remote regulatory assessment, or an inspection by a foreign authority under an agreement "reveals that an establishment is not operating in conformity with CGMPs," the manufacturing rules explained in our CGMP explainer.

In practice, records requests now drive much of this. In fiscal 2024, FDA added 75 sites to drug import alerts for quality reasons, the fiscal 2024 quality report¹¹ said. Sites in China made up 39 percent of those additions, India 13 percent and Europe 13 percent. More than 60 percent were based on records requests under section 704(a)(4) of the FD&C Act rather than an on-site visit. Makers of over-the-counter monograph products accounted for 65 percent of the additions, and active ingredient makers for 25 percent, many of them supplying compounding pharmacies.

A plant that will not let inspectors in faces a separate alert. A 2012 law made drugs from a facility that "delays, denies, or limits an inspection" adulterated, and Import Alert 66-79⁹ applies that rule at the border. FDA's text says listed firms "should remain subject to detention without physical examination until an FDA inspection is completed."

For generic drug plants, the path from inspection to import alert takes months. In fiscal 2025 the median time from a Form 483 to an import alert for facilities tied to generic applications was 144 days, according to FDA's GDUFA performance report to Congress¹². Our guide to inspections, Form 483s and warning letters covers the steps before that point, and our recalls and quality desk collects related coverage.

Getting off the list

Removal starts with a petition. FDA's removal page³ asks Red List firms to explain how the problem happened, what they fixed, what they did to prevent a repeat, and what evidence shows the fix works, offering "5 clean shipments" and third-party audits as examples.

For manufacturing problems, paperwork rarely ends it. The manual says firms listed after a violative inspection "may generally be removed" following a reinspection that confirms corrective actions. The 66-40 alert adds that when a listing is coupled with a warning letter or regulatory meeting, FDA "will generally conduct an inspection to confirm that corrective actions have been implemented" before removing the firm.

That can take years. For the 25 generic drug facilities whose warning letters, import alerts or regulatory meetings FDA tracked to resolution in its fiscal 2025 report, the median time from the final Official Action Indicated classification to resolution was 2,048 days, about five and a half years, the GDUFA report said. Some firms never get there. FDA wrote that in some instances firms "either chose not to remediate or never adequately remediate," and the compliance actions "indefinitely remain open."

A listing can also end quietly. FDA's FAQ notes that a firm can petition for removal if it no longer makes the product, and that a change in company name, ownership or location may change a firm's status. Readers who want to see whether a specific product was recalled, as opposed to stopped at the border, can search our recall records.

FDA updates the import alert databases in real time and publishes a weekly summary. On Nov. 2, 2026, it republished 66-41, the unapproved-drug alert that carries the longest Red List of any drug alert GxRadar counted.