D-0864-2026 Class II Ongoing
FDA drug recall D-0864-2026 was initiated by OurPharma LLC on September 3, 2026 and is designated Class II. 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). The recall status is ongoing. Affected quantity: 1,610 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- September 16, 2026
- Initiation Date
- September 3, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,610 bags
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.
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 Pattern
Nationwide within the U.S
Code Information
Lot #: 101301260605, BUD: 12/9/2026.