FDA Drug recall D-0864-2026
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,…
- FDA Drug
- Class II
- ongoing
- Published 2026-09-16
On 2026-09-16 the FDA classified a Class II recall of 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,… by Ourpharma, citing 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).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0864-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-09-03 |
| Published | 2026-09-16 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Ourpharma |
| Distribution | US |
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
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).
Identifiers
| code_info | Lot #: 101301260605, BUD: 12/9/2026. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Ourpharma
- HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville,…
FDA Drug · Class III · 2025-04-30 · Ourpharma - FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. C…
FDA Drug · Class III · 2023-02-01 · Ourpharma - FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma…
FDA Drug · Class II · 2022-12-21 · Ourpharma
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0864-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.