The FDA enforcement report lists a Class II recall (D-0864-2026) of fentanyl citrate 1,000 mcg per 100 mL (10 mcg/mL) in 0.9% sodium chloride, supplied in 100 mL IV bags by OurPharma LLC. The listed reason is a labelling issue: a complaint received on 31 August 2026 about a discrepancy between the expiry date on the IV bag (two different dates, 31 July 2026 and 30 November 2026) and the product expiry date (9 December 2026). The status is ongoing.
The entry does not report any patient harm, contamination or potency problem. For anaesthetists and pharmacies the practical point is that bags with conflicting dates cannot have their beyond-use status confirmed from the label.
- Check stock of premixed fentanyl 10 mcg/mL 100 mL bags against the recall listing for this supplier.
- Quarantine any bag whose labels show conflicting expiry dates and follow your pharmacy's recall procedure.
- The listing reports a labelling discrepancy, not a contamination or potency problem.
- Report any adverse event linked to affected stock through your usual system.
Why it matters
Premixed opioid infusions are used at the bedside and a label that cannot be trusted removes a basic safety check.
Don't overread it
A Class II labelling recall does not report harm or a defect in the drug itself.
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