FDA recall, , Moderate risk
OurPharma FentaNYL Citrate Injection Solution
FentaNYL Citrate Injection solution has a labeling discrepancy between the IV bag expiry and the product expiry.
Summary by Recall Canary from the FDA notice
What happened
OurPharma LLC of Fayetteville, Arkansas, is recalling fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag. The company began the recall on September 3, 2026, after a complaint received on 08/31/2026 reported a discrepancy between the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026). The product was distributed nationwide within the U.S.
The company's recall was added to the FDA's Enforcement Report on September 9, 2026, and classified by the FDA on September 21, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the lot code and NDC or UPC listed under your product.
A UPC is the number printed under a barcode. An NDC (National Drug Code) is usually printed on the drug's label.
fentaNYL Citrate, 1
- Strength
- 000 mcg
- UPC
- 101301260605
- Lot code
- 2026
- Recall number
- D-0864-2026
- NDC
- 73013-1013-01
Recall details
- Company began the recall
- Sold in
Nationwide within the U.S
- Company
- OurPharma LLCFayetteville, Arkansas
- Hazard
- Labeling error
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99837
- Recall number
- D-0864-2026
- Quantity recalled
- 1,610 bags
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
