FDA Drugs recall ·
fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100… recall
- Recall number
- D-0864-2026
- Date
- (initiated September 3, 2026)
- Company / brand
- OurPharma LLC
2512 S City Lake Rd, Fayetteville, AR, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,610 bags
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it 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).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 101301260605, BUD: 12/9/2026.
Distribution
Nationwide within the U.S
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0864-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.