FDAFDA recall D-0864-2026 · Sep 16, 2026
OurPharma LLC: fentaNYL Citrate recall
Recall found
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.
Reason for recall
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).
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot #: 101301260605, BUD: 12/9/2026.
- Quantity
- 1,610 bags
- Distribution
- Nationwide within the U.S
- Recalling firm
- OurPharma LLC, Fayetteville, AR
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-03
Source: openFDA enforcement record D-0864-2026 · search recall number D-0864-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.