{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,17]],"date-time":"2026-04-17T03:44:24Z","timestamp":1776397464374,"version":"3.51.2"},"reference-count":28,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,2,23]],"date-time":"2026-02-23T00:00:00Z","timestamp":1771804800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,2,23]],"date-time":"2026-02-23T00:00:00Z","timestamp":1771804800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>To characterize the frequency, causes, and severity of opioid medication recalls using United States Food and Drug Administration (FDA) Enforcement Reports.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We conducted a 2002\u20132025 descriptive analysis of recalls involving seven opioids. FDA free\u2010text recall reasons were categorized into five standardized domains (wrong dose\/potency, contamination, mispackaging\/mislabeling, defective delivery system, and quality assurance deviations) by two independent reviewers, with agreement assessed using Cohen's\n                      <jats:italic>\u03ba<\/jats:italic>\n                      (95% CI). Recall severity (Class I\u2013III) was compared across drugs using the chi\u2010square test, and temporal trends were evaluated with linear regression.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      We identified 286 opioid\u2010related recalls, involving over 350\u2009million units. Fentanyl (26.2% of events; &gt;\u200930\u2009million units), hydromorphone (20.3%; &gt;\u200911\u2009million), morphine (19.6%; &gt;\u200973\u2009million), oxycodone (12.6%; &gt;\u2009188\u2009million), and hydrocodone (13.9%; &gt;\u200950\u2009million) accounted for most events. Recalls of buprenorphine (7.0%; &gt;\u20093\u2009million) and methadone (3.2%; &gt;\u2009400 thousand) were less frequent. Quality assurance deviations accounted for most recalls (49.5%), followed by mispackaging\/mislabeling (14.4%), wrong dose\/potency (13.7%), defective delivery systems (12.3%), and contamination (10.1%). Inter\u2010rater agreement for categorization was high (\n                      <jats:italic>\u03ba<\/jats:italic>\n                      \u2009=\u20090.88 [0.84\u20130.93]). Class I recalls (risk of death) comprised 35 events (12.2%), concentrated among fentanyl (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200910), morphine (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20099), and hydromorphone (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20099) (\n                      <jats:italic>\u03c7<\/jats:italic>\n                      <jats:sup>2<\/jats:sup>\n                      \u2009=\u200943.1, df\u2009=\u200912,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001). Recall frequency increased significantly over time (\n                      <jats:italic>r<\/jats:italic>\n                      \u2009=\u20090.63,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.001). Unit count data were missing for 34 events (11.9%), and production denominators were unavailable.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Opioid recalls reflect manufacturing or quality assurance problems that may undermine product reliability. More complete recall reporting, including quantitative data, would support efforts to reduce risks associated with pharmaceutical quality failures.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.70341","type":"journal-article","created":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T17:45:16Z","timestamp":1772991916000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Characteristics of United States Food and Drug Administration Drug Recalls Involving Opioid Medications, 2002\u20132025"],"prefix":"10.1002","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9622-3361","authenticated-orcid":false,"given":"Julio C.","family":"Nunes","sequence":"first","affiliation":[{"name":"Department of Psychiatry Yale University School of Medicine  New Haven Connecticut USA"},{"name":"VA Connecticut Healthcare System  West Haven Connecticut USA"},{"name":"Clinical Neuroscience Research Unit (CNRU) Connecticut Mental Health Center (CMHC)  New Haven Connecticut USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabriel P. A.","family":"Costa","sequence":"additional","affiliation":[{"name":"Department of Psychiatry Yale University School of Medicine  New Haven Connecticut USA"},{"name":"Clinical Neuroscience Research Unit (CNRU) Connecticut Mental Health Center (CMHC)  New Haven Connecticut USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joao P.","family":"De Aquino","sequence":"additional","affiliation":[{"name":"Department of Psychiatry Yale University School of Medicine  New Haven Connecticut USA"},{"name":"VA Connecticut Healthcare System  West Haven Connecticut USA"},{"name":"Clinical Neuroscience Research Unit (CNRU) Connecticut Mental Health Center (CMHC)  New Haven Connecticut 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