Pharmacoepidemiol Drug Saf. 2026 Mar;35(3):e70341. doi: 10.1002/pds.70341.
ABSTRACT
PURPOSE: To characterize the frequency, causes, and severity of opioid medication recalls using United States Food and Drug Administration (FDA) Enforcement Reports.
METHODS: We conducted a 2002-2025 descriptive analysis of recalls involving seven opioids. FDA free-text 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 κ (95% CI). Recall severity (Class I-III) was compared across drugs using the chi-square test, and temporal trends were evaluated with linear regression.
RESULTS: We identified 286 opioid-related recalls, involving over 350 million units. Fentanyl (26.2% of events; > 30 million units), hydromorphone (20.3%; > 11 million), morphine (19.6%; > 73 million), oxycodone (12.6%; > 188 million), and hydrocodone (13.9%; > 50 million) accounted for most events. Recalls of buprenorphine (7.0%; > 3 million) and methadone (3.2%; > 400 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-rater agreement for categorization was high (κ = 0.88 [0.84-0.93]). Class I recalls (risk of death) comprised 35 events (12.2%), concentrated among fentanyl (n = 10), morphine (n = 9), and hydromorphone (n = 9) (χ2 = 43.1, df = 12, p < 0.001). Recall frequency increased significantly over time (r = 0.63, p = 0.001). Unit count data were missing for 34 events (11.9%), and production denominators were unavailable.
CONCLUSIONS: 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.
PMID:41725568 | DOI:10.1002/pds.70341
