Fentanyl Citrate Recall: OurPharma 1,000 mcg/100 mL Injection Bag
Recall involves OurPharma LLC fentanyl citrate injection solution in a 100 mL 0.9% NaCl bag distributed nationwide in the U.S. About 1,610 bags are affected; Lot 101301260605 with BUD 12/9/2026. The labeling is Not Elsewhere Classified, with a discrepancy between the bag expiry (07/31/2026) and the product expiry (12/09/2026).
| Brand | OurPharma LLC |
|---|---|
| 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). |
| Severity | unknown |
| Units affected | 1610 |
| Distribution | Nationwide within the U.S |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use the affected fentanyl citrate IV bags bearing Lot 101301260605 or with the expiry discrepancy; quarantine per facility policy.
- Contact your hospital, pharmacy, or supplier to arrange replacement or proper disposal per recall instructions.
- If you or a patient has used an affected bag, inform the clinician immediately and monitor for any adverse effects.
How to identify the recalled item
| Lot / date codes | Lot #: 101301260605, BUD: 12/9/2026. |
|---|---|
| Lot / date codes | Lot #: 101301260605, BUD: 12/9/2026. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.