Quality & compliance

GMP and GDP, inspections, quality-defect recalls, warning letters, data integrity and enforcement.

14 November 2026
Quality & complianceOfficial

Class II drug recall: fentaNYL Citrate (Ourpharma Llc)

Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026). Recall D-0864-2026; status Ongoing; distribution: Nationwide within the U.S.

🇺🇸 FDA enforcement report · Wed 16 Sep 2026

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.