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.
Keywords: analgesics; drug safety; medications for opioid use disorder; opioid safety; opioids; pain management; pharmacovigilance.
Opioid medications are widely used for pain treatment and for opioid use disorder, yet little is known about how often these products are recalled or why. We reviewed more than 20 years of recall data from the United States Food and Drug Administration and found 286 recalls involving seven commonly used opioids, affecting over 350 million tablets, capsules, patches, and injectable products. Nearly half of these recalls occurred because products failed basic quality checks, while others involved incorrect doses, contamination, mislabeling, or defective delivery systems. The most serious recalls, those carrying risk of serious injury or death, were concentrated among fentanyl, morphine, and hydromorphone. Many recall notices lacked important details, including the number of units affected, making it difficult to understand how these issues may impact patients. Our findings show that opioid recalls happen regularly and often reflect manufacturing problems that could influence treatment safety or effectiveness. Clearer and more complete reporting of recall information would help clinicians, patients, and regulators better understand these events and support safer use of opioid medications.
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