FDA recall D-0864-2026

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).

Distribution

Nationwide within the U.S

Key facts

Status

Ongoing

Initiation date

2026-09-03

Report date

2026-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fayetteville, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0864-2026