Characteristics of United States Food and Drug Administration Drug Recalls Involving Opioid Medications, 2002-2025 - PubMed
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- 286 opioid-related recalls identified from 2002-2025, affecting over 350 million units.
- Fentanyl, hydromorphone, morphine, oxycodone, and hydrocodone accounted for most recalls.
- Quality assurance deviations were the leading cause of recalls (49.5%).
- Class I recalls (risk of death) comprised 12.2% of events, concentrated in fentanyl, morphine, and hydromorphone.
- Recall frequency increased significantly over time (r = 0.63, p = 0.001).
- Incomplete recall reporting, including missing unit counts, limits understanding of patient impact.