The FDA enforcement report lists an ongoing Class II recall, dated 16 September 2026, of fentanyl citrate 1,000 mcg in 100 mL (10 mcg/mL) in 0.9% sodium chloride bags made by OurPharma LLC, a US compounder. A complaint on 31 August reported that the expiry printed on the IV bag differed from the product expiry date.
This is a labelling discrepancy, not a reported contamination or potency failure. Class II means use may cause temporary or reversible harm, or that serious harm is remote. The product is supplied in the US; there is no indication it reaches Indian hospitals.
- No action is needed unless your institution sources this compounded product.
- Check expiry on both the outer label and the bag of any premixed opioid infusion.
- Quarantine and report any infusion bag with conflicting expiry dates to pharmacy.
- Treat premixed high-concentration opioid bags as high-alert medicines.
Why it matters
Labelling errors on high-alert infusions are how wrong-product and out-of-date drugs reach patients.
Don't overread it
The recall concerns labelling, not a confirmed problem with the drug itself.
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