RecallRadar
ModerateReported September 16, 2026 (3 weeks ago)

fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in…

Recalled by OurPharma LLC

Drug recall

OurPharma LLC

Class II — moderate

Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

OurPharma LLC has recalled fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in…, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on September 16, 2026 and was initiated on September 3, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in…, with approximately 1,610 bags affected. The company behind the recall is OurPharma LLC, based in Fayetteville, AR. The FDA describes the product as: “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 fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in… recalled?

According to the FDA, the stated reason for the recall is: “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?

If you think you may have bought fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in…, compare it against the product description and identifying codes (Lot #: 101301260605, BUD: 12/9/2026.) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact OurPharma LLC or your local health authority.

About this recall

This recall was distributed in AR. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.

Who this recall affects

This recall matters to anyone who bought fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in…. Even if you feel fine, it's worth checking what you have on hand rather than assuming you were missed.

Distribution listed in the notice: Nationwide within the U.S.

How to check whether you have it

On medicine bottles, the lot number and expiration date are printed on the pharmacy label or stamped directly on the manufacturer's bottle — often near the bottom edge or on the back. If a pharmacy label covers it, your pharmacist can look up the lot they dispensed.

Compare what you find against the identifying details in this recall: Lot #: 101301260605, BUD: 12/9/2026.

What to do if you already bought it

Do not stop taking a prescribed medicine on your own because of a recall — for many conditions, an interrupted dose carries its own risk.

Instead, check the lot number against the details above and contact your pharmacist, who can confirm what they dispensed and arrange a replacement.

If you've had an unexpected reaction, contact your healthcare provider. Problems can also be reported to the FDA's MedWatch program.

Full recall details

Status
Ongoing
Date reported
September 16, 2026
Recall started
September 3, 2026
Distributed in
AR
What was recalled
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 it was recalled (as stated by the FDA)
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).
How to identify the affected product
Lot #: 101301260605, BUD: 12/9/2026.
Amount recalled
1,610 bags

What you can do

Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.

Quick answers

Why was fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in… recalled?+

According to the FDA: Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of…

How serious is this recall?+

Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

What should I do if I have fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in…?+

Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.

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View the official FDA record →

Opens the U.S. Food and Drug Administration (FDA) data for this recall.

Recall number: D-0864-2026. Information last synced from the FDA on October 6, 2026.