FDA-Drug2026-05-27Class IIMISBRANDING
IntegraDose fentanyl citrate injection recalled for subpotent drug strength
What this means
IntegraDose Compounding Services LLC has recalled fentanyl citrate sterile injection (2,250 mcg/50 mL) because the drug may contain less active ingredient than labeled. This lot was distributed nationwide to healthcare facilities.
- Check if your facility received lot #20260310FEN-1 (expiration 09/06/2026).
- Do not use affected cassettes for patient injections.
- Contact IntegraDose Compounding Services LLC or your pharmacy supplier for return instructions.
- Consult your healthcare provider about alternative fentanyl sources if needed for patient care.
The agency's original wording
Hazard
Subpotent Drug
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide.
Affected count
376 cassettes
Manufactured in
3650 Victoria St N Ste 900, Shoreview, MN, United States
Products
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0548-2026Want us to check the next one for you?
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