The revision of this Import Alert (IA) dated 09/30/2025 updates the guidance section including agency contacts and PAC. Changes to the import alert are bracketed by asterisks (***). The Food and Drug Administration (FDA) collects and analyzes samples of drugs, including finished dosage drug products and active pharmaceutical ingredients, considered at risk for adulteration that pose a health risk due to contamination, substandard quality, or ingredient substitution. Detention without physical examination may be appropriate when analytical test results reveal a potential health risk.
Various Drugs (refer to Red List)
For finished dosage drug products and active pharmaceutical ingredients that appear to be adulterated due to harmful impurities: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health. [Adulteration, Section 501(a)(2)(A)] OASIS Charge Code - INSANITARY AND/OR For finished dosage drug products and active pharmaceutical ingredients that appear to be adulterated due to Current Good Manufacturing Practice violations: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B). [Adulteration, Section 501(a)(2)(B)] OASIS Charge Code - DRUG GMPS AND/OR For finished dosage drug products and active pharmaceutical ingredients that appear to be adulterated because its strength differs from, or its quality or purity falls below the standard set forth in an official compendium recognized by the FD&C Act: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium. [Adulteration, Section 501(b)]. OASIS Charge Code - DR QUALITY AND/OR For finished dosage drug products and active pharmaceutical ingredients whose name is not recognized in an official compendium and that appears to be adulterated because its strength differs from, or its quality or purity falls below, that which it purports or is represented to possess: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess. [Adulteration, Section 501(c)] OASIS Charge Code - DR QUALITC AND/OR For finished dosage drug products and active pharmaceutical ingredients that appear to be adulterated because they have been mixed or packed therewith so as to reduce quality or strength: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug that a substance has been mixed or packed with so as to reduce its strength. [Adulteration, 501(d)(1)] OASIS Charge Code - REDUCED AND/OR For finished dosage drug products and active pharmaceutical ingredients that appear to be adulterated because it has been substituted wholly or in part therefor: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug that a substance has been substituted wholly or in part. [Adulteration, 501(d)(2)] OASIS Charge Code - SUBSTITUTE
Divisions may detain without physical examination (DWPE) shipments of the drugs that appear to be adulterated, listed on the Red List of this Import Alert. NOTE: This Import Alert does not apply to contamination in drugs based on microbial test results. Please refer to Import Alert 55-05. Divisions should follow the guidance in the Regulatory Procedures Manual (RPM) Chapter 9-2 for Personal Importation shipments. Commercial or promotional shipments, and products subject to DWPE are generally not amenable to the use of enforcement discretion. ***The evidence to support recommendations for addition to the Red List of this Import Alert will be evaluated by CDER/OC/ODSIR/DGDD/ICB on a case-by-case basis. Recommendations should include background information, analytical worksheets, product labeling, and entry documents. 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 Under This Import Alert: DWPE of the drugs listed on the Red List of this Import Alert remains in effect until such time as FDA is satisfied that the appearance of a violation has been removed. In order to secure release of an individual shipment subject to DWPE under this Import Alert, the importer and/or another responsible party to the shipment should provide evidence that the shipment does not contain drugs that appear to be adulterated. CDER/OC/ODSIR/DGDD/ICB will evaluate on a case-by-case basis. To inform FDA's assessment of these shipments and whether the appearance of a violation has been overcome, the firm may provide documentation, including the results of third-party laboratory analyses of a representative sample, using analytical methods that provide results to demonstrate that the firm has addressed the conditions that gave rise to the appearance of a violation. As part of its evaluation of such laboratory analyses, FDA may consider whether the laboratory has been previously inspected by FDA and found to be in compliance with Current Good Manufacturing Practice (CGMP) requirements. Removal from DWPE (REMOVE FROM RED LIST): To request removal of a firm's drugs 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 Federal Food, Drug, and Cosmetic Act. This information may include, but is not limited to, a letter detailing its corrective actions, accompanied by documentation. FDA might also determine that it is appropriate to verify a firm's corrective actions through an inspection prior to the Agency considering the appearance of adulteration to be addressed. In accordance with Chapter 9 of the Regulatory Procedures Manual (RPM), a minimum of five (5) consecutive non-violative commercial shipments may be required before the Agency can consider that the appearance of a violation has been overcome. For further guidance on removal from DWPE, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE)," available at: https://www.fda.gov/media/71776/download. ***If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov*** Requests for removal from DWPE will be referred by DIO to ***CDER/OC/ODSIR/DGDD/ICB*** for evaluation. ***Questions or issues involving import operations or the submission of petitions for removal from DWPE should be addressed to OII/DIO (301) 796-0356 or Imports@fda.hhs.gov*** Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov. Questions or issues involving compliance of imported drugs and drug products should be addressed to the CDER Imports Compliance Branch at CDERImports@fda.hhs.gov. *** ***
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: The revision of this Import Alert (IA) dated 09/30/2025 updates the guidance section including agency contacts and PAC. Changes to the import alert are bracketed by asterisks (***). The Food and Drug Administration (FDA) collects and analyzes samples of drugs, including finished dosage drug products and active pharmaceutical ingredients, considered at risk for adulteration that pose a health risk due to contamination, substandard quality, or ingredient substitution. Detention without physical examination may be appropriate when analytical test results reveal a potential health risk.
Country-specific information is available in the full alert detail on the FDA website.
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