fentaNYL Citrate recall
FDA recall D-0864-2026 · initiated Sep 3, 2026
OurPharma LLC recalled fentaNYL Citrate in Sep 2026 — an FDA Class II recall (D-0864-2026) because 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).
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
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).
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
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: 1,610 bags
Details
- Product
- fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.
- Recalling company
- OurPharma LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the U.S
- Initiated
- Sep 3, 2026
- FDA report date
- Sep 16, 2026
Frequently asked
- Was fentaNYL Citrate recalled?
- OurPharma LLC recalled fentaNYL Citrate in Sep 2026 — an FDA Class II recall (D-0864-2026) because 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). 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-0864-2026 was: 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).
- 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 within the U.S. The recall covers these lots — Lot #: 101301260605, BUD: 12/9/2026.. 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-0864-2026.