Import Alert 68-20

Import Alert # 68-20

Published Date: 03/04/2026

Type: DWPE with Surveillance

“DETENTION WITHOUT PHYSICAL EXAMINATION OF ***ANIMAL DRUGS WHICH ARE SUBJECT TO HUMAN DIVERSION/MISUSE”***

NOTE: The revision of this Import Alert dated 3/4/2026 updates the import alert title, reason for alert, guidance, product description, product codes and charge codes. Changes are bracketed by asterisks (***).

***Certain animal drugs have established uses in veterinary medicine but present risks for diversion to human use (primarily diversion to the illicit drug supply) and/or misuse by humans. Unless otherwise specified, this import alert applies to drugs containing the following active moieties:

- Xylazine (including xylazine hydrochloride), including APIs and drug products
- Medetomidine (including medetomidine hydrochloride), including APIs and drug products.

Xylazine: Xylazine (and xylazine hydrochloride) is a non-opioid agent that is the active ingredient in an animal drug which FDA originally approved in 1972 as a sedative and analgesic. It is used in many different animal species including dogs, cats, horses and Cervidae (certain species of deer and elk).

There are no drugs containing xylazine that are approved for use in humans, and FDA is not aware of any legitimate medical use of xylazine in humans. Xylazine has been repeatedly detected in the illicit drug supply (particularly with heroin and illicit forms of fentanyl) and in human drug overdoses and deaths from such illicit drugs; however, individuals who use illicit drugs may not be aware of xylazine's presence in drugs that they are using. Xylazine causes similar symptoms to those commonly associated with opioid use, making it difficult to distinguish opioid overdoses from xylazine exposure. Therefore, in an effort to protect public health and safeguard against unsafe, non-veterinary use, FDA is issuing this import alert for drugs containing xylazine that are or appear to be adulterated or misbranded.

Medetomidine: Medetomidine (including medetomidine hydrochloride) is a veterinary sedative and analgesic in the same pharmacologic class as xylazine. Medetomidine has also been detected in the illicit drug supply and presents similar risks to humans as xylazine. Therefore, in an effort to protect public health and safeguard against unsafe, non-veterinary use, FDA is issuing this import alert for drugs containing medetomidine that are or appear to be adulterated or misbranded.

Note: This import alert does not apply to dexmedetomidine, which is an active moiety used in human drugs. Dexmedetomidine should be screened using existing procedures for human drug imports and supply chain controls.

Under section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), drugs must have labeling that bears adequate directions for use, unless the drug is subject to exemptions from labeling found in 21 CFR Part 201. A drug in a bulk package (including APIs, but not including tablets, capsules, or other dosage unit forms) intended for processing, repacking, or use in the manufacture of another drug is exempt from the requirements of 502(f)(1) if certain conditions are met pursuant to 21 CFR 201.122. More specifically, if an API is intended for a use that causes the finished article to be a new animal drug, the API will be exempt from section 502(f)(1) if it bears certain required labeling and: (1) an approved application covers the production and delivery of the API to the application holder by persons named in the application; (2) delivery is made only to manufacture a new animal drug limited to investigational use as provided; or (3) a pending application covers the use of the API in the production of a finished drug product, and the finished drug product is not further distributed after it is manufactured until the application is approved.***

***Divisions may detain, without physical examination (DWPE), shipments of:
- xylazine bulk drug, xylazine API (including xylazine hydrochloride), and drug products containing xylazine; and
- medetomidine bulk drug, medetomidine API (including medetomidine hydrochloride), and drug products containing medetomidine;
which are identified on the Red List of this Import Alert.

Divisions may also detain articles containing these active moieties that are, or appear to be, misbranded drugs under section 502(f)(1).
For any shipment containing these active moieties that is not on the Red List, contact Center for Veterinary Medicine (CVM)/Division of Drug Compliance at cvmimportrequests@fda.hhs.gov to determine whether the article meets one of the exemptions in 21 CFR Part 201.

Divisions may also detain shipments of drug products containing these active moieties that are, or appear to be, adulterated under section 501(a)(5). For any shipment of drug product containing these active moieties that is not on the Red List, contact CVM/Division of Drug Compliance at cvmimportrequests@fda.hhs.gov to determine whether the article is approved or is subject to an Investigational New Animal Drug (INAD).***

The evidence to support recommendations for addition to the Red List of this Import Alert will be evaluated by CVM on a case-by-case basis. Final recommendations for DWPE additions to the Red List will be reviewed by the Division of Import Operations (DIO).

Release of Articles Subject to Detention Without Physical Examination:

In order to secure release of an individual entry shipment subject to DWPE under this import alert, that has been detained, the importer should provide documentation which verifies the product has a valid New Animal Drug Application (NADA) or abbreviated NADA (ANADA), conditionally approved NADA (CNADA), index listing, or Investigational New Animal Drug exemption (INAD) and Generic Investigational New Animal Drug exemption.

Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration, per the notice of detention.


Removal from Detention without Physical Examination (REMOVE FROM RED LIST):

In order to remove a firm’s product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the FD&C Act. For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to petition for removal from DWPE under this Import Alert, all relevant information supporting the request should be sent via email to:
Importalerts2@fda.hhs.gov

Questions or issues involving import operations or the submission of petitions for removal from DWPE should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.

Questions or issues on policy or other additional technical questions should be addressed to Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance (CVM/OSC/DDC) at CVMImportRequests@fda.hhs.gov

                                                                                                                                                                  

***Xylazine Active Pharmaceutical Ingredients (APIs), xylazine hydrochloride, xylazine bulk drug, and unapproved xylazine finished product, Medetomidine Active Pharmaceutical Ingredients (APIs), medetomidine hydrochloride, medetomidine bulk drug, and unapproved drug products containing medetomidine***

Product Code: ***60L[][]71, 60C[][]14***

***Use for bulk drugs / APIs:***
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use. [Misbranding, Section 502(f)(1)]

OASIS charge code: DIRSEXMPT

***Use for unapproved Finished Animal Drug Products:***
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies. [Adulteration, Section 501(a)(5)]

OASIS charge code: NEW VET DR

Desc: XILAZIL (Xilazina al 10%)

Desc: XILAZINA 10% VETEC

Desc: EQUIET XILACINA 10% Injectable Solution

Desc: EQUIET XILACINA 10% Injectable Solution

Desc: XYLAZINE INJECTION 2%W/V (Xzin)

Desc: XYLAZINE INJECTION 2%

Desc: XYLAZINE INJECTION U.S.P. (XYLAXIN)

Desc: Premier Line Xilacina Inyeccion

Desc: XILAGAL 10%

Desc: Xylazine HCl 20 mg