U.S. Food and Drug Administration (FDA) Restricts Imports of Xylazine, the Animal Sedative in Street Drugs (2023)
On 28 February 2023 the U.S. Food and Drug Administration announced that it had taken action “to restrict the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into the country.” Xylazine is a sedative that veterinarians use on large animals such as horses and deer. The U.S. Food and Drug Administration (FDA) acted because, in its words, the chemical “has increasingly been found in illicit drugs such as illicitly manufactured fentanyl and other drugs and increasingly detected in overdose deaths.” The tool it used was an import alert, which puts incoming shipments of xylazine under heightened scrutiny while keeping the drug available for animal care.
This page reports what the U.S. Food and Drug Administration documents say: what the agency did and when, what xylazine is, why the U.S. Food and Drug Administration acted, the harms it described, how the import alert works and which imports stay allowed, the agency’s earlier November 2022 alert to health care professionals, enforcement, what the action does not do, its status as of 18 October 2026, and how it fits other U.S. Food and Drug Administration actions. No company, importer or product is named here. The wider medical picture is on the site’s Opioid Overdose page.
Table of Contents
- What the U.S. Food and Drug Administration Did
- What Xylazine Is
- Why the U.S. Food and Drug Administration Acted: Xylazine in the Illicit Drug Supply
- The Harms the U.S. Food and Drug Administration Described
- How the Import Alert Works
- Which Imports Stay Allowed
- The November 2022 Alert to Health Care Professionals
- Enforcement and Partner Agencies
- What the Action Does Not Do
- Dates and Legal Status as of 18 October 2026
- How the Action Fits Other U.S. Food and Drug Administration Actions
- Primary Documents
- Key Research Papers
- Connections
- Featured Videos
1. What the U.S. Food and Drug Administration Did
The U.S. Food and Drug Administration news release of 28 February 2023, “U.S. Food and Drug Administration Takes Action to Restrict Unlawful Import of Xylazine,” carries the subtitle “Agency Aims to Maintain Availability for Legitimate Use in Animals while Preventing Importation for Illicit Purposes.” It states that the agency had acted to restrict the unlawful entry of two forms of xylazine:
- Active pharmaceutical ingredients — the drug substance itself, before it is made into a finished medicine.
- Finished dosage form drug products — the completed medicine, ready to use.
The release describes the purpose in one sentence: “This action aims to prevent the drug from entering the U.S. market for illicit purposes, while maintaining availability for its legitimate uses in animals.” The measure was an import alert (described in section 5). The release links to the import alert itself on the U.S. Food and Drug Administration’s import-alert database, which could not be reached for this page, so the alert’s own wording is not reported here.
The U.S. Food and Drug Administration Commissioner called the step “one part of broader efforts the agency is undertaking to address this issue” and said the agency would “continue to use all tools at our disposal and partner with the Drug Enforcement Administration and other federal, state, local agencies and stakeholders as appropriate to stem these illicit activities and protect public health.”
2. What Xylazine Is
According to the 2023 release, “Veterinarians legitimately use drug products containing xylazine to sedate large animals such as horses and deer, but it is not safe for use in people and may cause serious and life-threatening side effects.”
The U.S. Food and Drug Administration’s November 2022 alert adds that xylazine “is U.S. Food and Drug Administration-approved for use in animals as a sedative and pain reliever.” It has no human use described in either document; the alert states plainly that xylazine “is not safe for use in humans.”
Both documents stress one point about what xylazine is not: the 2023 release states that “xylazine is not an opioid.” That matters because the medicine used to reverse opioid overdoses, naloxone, works on opioids (see section 7).
3. Why the U.S. Food and Drug Administration Acted: Xylazine in the Illicit Drug Supply
The release gives the reason for the action as “a growing public health concern”: xylazine “has increasingly been found in illicit drugs such as illicitly manufactured fentanyl and other drugs and increasingly detected in overdose deaths.”
The U.S. Food and Drug Administration describes xylazine as a contaminant found in two kinds of illicit drug mixtures:
- combined with opioids such as illicit fentanyl, and
- combined with other illicit products that contain stimulants such as methamphetamine and cocaine.
The release adds a point about awareness: “People who use illicit drugs may not be aware of the presence of xylazine.”
On where the xylazine was coming from, the November 2022 alert stated that “It is not known at this time whether the xylazine used in these scenarios is illicitly produced (unapproved) or diverted from the animal drug supply,” and that the U.S. Food and Drug Administration was continuing to investigate its source. The February 2023 release does not report an answer to that question.
4. The Harms the U.S. Food and Drug Administration Described
The release lists the dangers in plain terms. Although it is not an opioid, xylazine “is dangerous because it can depress breathing, blood pressure, heart rate and body temperature to critical levels.”
It also describes wounds:
- People who inject drugs containing xylazine “can develop severe skin wounds and patches of dead and rotting tissue that easily become infected.”
- If left untreated, these wounds “may lead to amputation.”
- “These wounds can develop in areas of the body away from the injection site and may become life-threatening.”
The November 2022 alert described the wounds as “severe, necrotic skin ulcerations” (necrotic means the tissue has died). It also noted that the side effects of xylazine “appear to be similar to those commonly associated with opioid use, making it difficult to distinguish opioid overdoses from xylazine exposure,” and that the U.S. Food and Drug Administration was “aware of increasing reports of serious side effects” in people exposed to fentanyl, heroin and other illicit drugs contaminated with xylazine. Wound care in general is covered on the site’s Wound Healing page.
5. How the Import Alert Works
The release describes what the import alert does: “Under the import alert, xylazine offered for import is subject to heightened U.S. Food and Drug Administration scrutiny, and U.S. Food and Drug Administration staff may detain the shipment if it appears to be in violation of the law.” To detain a shipment means to hold it rather than let it enter the country.
Importers can offer evidence that a shipment is lawful. In the release’s words: “As part of their entry review, U.S. Food and Drug Administration staff will consider specific evidence offered by importers that the incoming product is properly labeled, not adulterated, and for legitimate veterinary use.”
The action was announced in a news release. The documents fetched for this page include no Federal Register notice, rule or public docket for it, and the import alert’s number and exact scope, which appear only on the U.S. Food and Drug Administration’s import-alert database, are not given here.
6. Which Imports Stay Allowed
The action was not designed to stop xylazine from reaching veterinarians. The release states that it “is designed to ensure that imports of drugs containing xylazine into the country are intended for the legitimate veterinary supply,” and it names three kinds of legitimate imports:
- Ingredients for approved manufacturing: active pharmaceutical ingredients “en route for processing by a manufacturing facility that makes U.S. Food and Drug Administration-approved xylazine.”
- Animal-drug compounding: supplies “for compounding of animal drugs at state-licensed compounding pharmacies or by licensed veterinarians.” Compounding means preparing a medicine to order rather than buying a mass-produced one.
- Approved finished products: “approved finished products being imported into the U.S.”
The director of the U.S. Food and Drug Administration’s Center for Veterinary Medicine said the agency was “continuing to ensure that legitimate product is restricted to veterinary use only.” The release adds that the agency “is coordinating with animal health stakeholders to ensure that drugs containing xylazine are available to veterinarians for legitimate use.”
7. The November 2022 Alert to Health Care Professionals
The 2023 release notes that the agency had “previously communicated to health care providers about the risks to patients exposed to xylazine in illicit drugs.” That earlier step was a U.S. Food and Drug Administration drug alert dated 8 November 2022, “U.S. Food and Drug Administration alerts health care professionals of risks to patients exposed to xylazine in illicit drugs.” Its main points:
- Naloxone may not work on xylazine. The alert warned of possible xylazine in fentanyl, heroin and other illicit drug overdoses, “as naloxone may not be able to reverse its effects,” and stated that “we do not know if side effects from xylazine exposure can be reversed by naloxone.”
- Naloxone still has a role. The U.S. Food and Drug Administration told health care professionals to continue giving naloxone for opioid overdoses, and to consider xylazine exposure when patients do not respond to naloxone or show signs of xylazine exposure such as severe, necrotic skin ulcers. It called for supportive care for patients who do not respond.
- Veterinary reversal drugs. The alert stated that it is not known whether the reversal agents used in veterinary medicine (it names yohimbine hydrochloride and tolazoline hydrochloride) are safe or effective in humans, and the U.S. Food and Drug Administration advised against their use in people.
- Standard drug tests miss it. “Routine toxicology screens do not detect xylazine,” and additional laboratory techniques are needed to find it.
- A letter to stakeholders. The U.S. Food and Drug Administration also issued a letter giving clinical information on the risk of severe skin ulcers from repeated exposure, possible withdrawal symptoms, and xylazine’s interference with successful treatment of opioid overdoses.
- Reporting. The U.S. Food and Drug Administration asked health care professionals and patients to report adverse events in humans linked to possible illicit xylazine exposure to its MedWatch program.
Naloxone itself is the subject of another 2023 action: the approval of naloxone nasal spray for sale without a prescription.
8. Enforcement and Partner Agencies
Besides the import alert, the release describes investigative work. “The U.S. Food and Drug Administration and its Office of Criminal Investigations is collaborating with federal, state and local partners to investigate xylazine-related activities that could be subject to criminal prosecution, including online and in-person conduct.”
The Commissioner’s statement names the Drug Enforcement Administration (DEA) as a partner. The release ends with the agency’s note that it “will continue to provide updates on this work as appropriate.”
9. What the Action Does Not Do
- It does not ban xylazine. The action aims at “maintaining availability for its legitimate uses in animals,” and lawful veterinary imports continue (section 6).
- It does not change xylazine’s legal classification. The U.S. Food and Drug Administration documents describe no change to how xylazine is treated under federal drug-control law; neither document describes it as a controlled substance or announces a move to make it one.
- It does not address xylazine already in the illicit supply. The import alert concerns shipments offered for import; the release describes criminal investigations as separate work.
- It does not approve any human use. Both documents state that xylazine is not safe for use in people.
- It does not change naloxone’s role. Xylazine is not an opioid, and the 2022 alert told clinicians to keep giving naloxone for opioid overdoses.
10. Dates and Legal Status as of 18 October 2026
- 8 November 2022 — U.S. Food and Drug Administration drug alert to health care professionals on the risks of xylazine in illicit drugs (background).
- 28 February 2023 — U.S. Food and Drug Administration news release announcing the action to restrict unlawful xylazine imports under an import alert. (The release page shows “content current as of 02/21/2023”; its release date reads 28 February 2023, which is the date used here.)
Status as of 18 October 2026: announced as in effect in February 2023; current status not independently confirmed. The import alert itself sits on the U.S. Food and Drug Administration’s import-alert database, which could not be reached for this page, so whether its text has since been changed is not reported. A check of the Federal Register from 1 January 2023 through 18 October 2026 for “xylazine” found no U.S. Food and Drug Administration document on xylazine imports or on controlling xylazine; the only U.S. Food and Drug Administration documents it returned were an animal-drug application rule (9 May 2025) and an international drug-scheduling notice (26 August 2026) whose title does not list xylazine among the substances under review.
11. How the Action Fits Other U.S. Food and Drug Administration Actions
The documents present the import alert as a second step. The U.S. Food and Drug Administration’s November 2022 alert warned clinicians and said the agency was investigating where illicit xylazine came from; the February 2023 action moved to the border. The Commissioner called the import step “one part of broader efforts the agency is undertaking to address this issue.”
The same year, the U.S. Food and Drug Administration took other steps on opioids and overdose, reported on their own pages: over-the-counter naloxone nasal spray and new safety labeling for opioid pain medicines, which was followed by further opioid labeling changes on long-term use (2025). Later U.S. Food and Drug Administration actions on substances sold or used outside approved medical use include the 2024 warning to retailers about tianeptine and the 2025 move against concentrated 7-OH kratom products. All 2023 actions are listed on the U.S. Food and Drug Administration Actions of 2023 hub.
12. Primary Documents
- U.S. Food and Drug Administration (2023). U.S. Food and Drug Administration Takes Action to Restrict Unlawful Import of Xylazine. U.S. Food and Drug Administration News Release, 28 February 2023. No Federal Register citation or docket — fda.gov news release
- U.S. Food and Drug Administration (2022). U.S. Food and Drug Administration alerts health care professionals of risks to patients exposed to xylazine in illicit drugs. U.S. Food and Drug Administration Drug Alerts and Statements, 8 November 2022. No Federal Register citation or docket — fda.gov drug alert
- U.S. Food and Drug Administration. Import alert on xylazine, linked from the 28 February 2023 release on the U.S. Food and Drug Administration import-alert database (accessdata.fda.gov). Not reachable for this page; its number and wording are not reported.
Key Research Papers
- Kariisa M, Patel P, Smith H, Bitting J (2021). Notes from the Field: Xylazine Detection and Involvement in Drug Overdose Deaths – United States, 2019. MMWR Morbidity and Mortality Weekly Report 70(37):1300-1302 — PubMed PMID: 34529640
- Thangada S, Clinton HA, Ali S, Nunez J, Gill JR, Lawlor RF, Logan SB (2021). Notes from the Field: Xylazine, a Veterinary Tranquilizer, Identified as an Emerging Novel Substance in Drug Overdose Deaths – Connecticut, 2019-2020. MMWR Morbidity and Mortality Weekly Report 70(37):1303-1304 — PubMed PMID: 34529638
- Kariisa M, O'Donnell J, Kumar S, Mattson CL, Goldberger BA (2023). Illicitly Manufactured Fentanyl-Involved Overdose Deaths with Detected Xylazine – United States, January 2019-June 2022. MMWR Morbidity and Mortality Weekly Report 72(26):721-727 — PubMed PMID: 37384558
- Cano M, Daniulaityte R, Marsiglia F (2024). Xylazine in Overdose Deaths and Forensic Drug Reports in US States, 2019-2022. JAMA Network Open 7(1):e2350630 — PubMed PMID: 38180756
- Ball NS, Knable BM, Relich TA, Smathers AN, Gionfriddo MR, Nemecek BD, Montepara CA, Guarascio AJ, Covvey JR, Zimmerman DE (2022). Xylazine poisoning: a systematic review. Clinical Toxicology (Philadelphia) 60(8):892-901 — PubMed PMID: 35442125
- Ruiz-Colón K, Chavez-Arias C, Díaz-Alcalá JE, Martínez MA (2014). Xylazine intoxication in humans and its importance as an emerging adulterant in abused drugs: A comprehensive review of the literature. Forensic Science International 240:1-8 — PubMed PMID: 24769343
- Tosti R, Hozack BA, Tulipan JE, Criner-Woozley KT, Ilyas AM (2024). Xylazine-Associated Wounds of the Upper Extremity: Evaluation and Algorithmic Surgical Strategy. Journal of Hand Surgery Global Online 6(5):605-609 — PubMed PMID: 39381381
The first four papers are public-health reports on xylazine detected in overdose deaths and in drug seizures in the United States, two of them published in 2021, before the U.S. Food and Drug Administration acted. The next two are reviews of reported human xylazine poisoning; the last is a review of the arm and hand wounds associated with xylazine.
PubMed Topic Searches
Connections
- U.S. Food and Drug Administration Actions of 2023
- U.S. Food and Drug Administration and Regulation
- Opioid Overdose
- Addiction and Substance Use Disorders
- Wound Healing
- Opioids for Chronic Non-Cancer Pain
- Over-the-Counter Naloxone Nasal Spray (2023)
- Opioid Pain Medicine Label Updates (2023)
- Opioid Long-Term Use Label Changes (2025)
- Tianeptine Retailer Warning (2024)
- Concentrated 7-OH Kratom Products (2025)