fentaNYL Citrate recall
FDA recall D-0548-2026 · initiated May 12, 2026
IntegraDose Compounding Services LLC recalled fentaNYL Citrate in May 2026 — an FDA Class II recall (D-0548-2026) because Subpotent Drug.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent Drug
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 376 cassettes
Details
- Product
- 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.
- Recalling company
- IntegraDose Compounding Services LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide.
- Initiated
- May 12, 2026
- FDA report date
- May 27, 2026
Frequently asked
- Was fentaNYL Citrate recalled?
- IntegraDose Compounding Services LLC recalled fentaNYL Citrate in May 2026 — an FDA Class II recall (D-0548-2026) because Subpotent Drug. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was fentaNYL Citrate recalled?
- Per the FDA enforcement record, the reason for recall D-0548-2026 was: Subpotent Drug
- Is a recalled fentaNYL Citrate dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of fentaNYL Citrate are affected?
- Distributed: Nationwide.. The recall covers these lots — Lot#: 20260310FEN-1, Exp. Date: 09/06/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0548-2026.