← FDA ENFORCEMENT
drug-20260916-OurPharma LLCNot Yet Classified

OurPharma LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
OurPharma LLC
Product type
Drug
Status
Ongoing
Report date
2026-09-16
Distribution
Nationwide within the U.S
Firm state
AR
Product quantity
1,610 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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).

Product description

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.

Code / lot info

Lot #: 101301260605, BUD: 12/9/2026.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →