Why it was 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).
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 101301260605, BUD: 12/9/2026.
Where it was sold
Nationwide within the U.S
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0864-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 3, 2026
- FDA report date
- Sep 16, 2026
- Quantity
- 1,610 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- OurPharma LLC
Original FDA data
Every field from FDA enforcement report D-0864-2026, exactly as published.
Show all FDA fields
- City
- Fayetteville
- State
- AR
- Status
- Ongoing
- Country
- United States
- Event ID
- 99837
- Address
- 2512 S City Lake Rd
- Code information
- Lot #: 101301260605, BUD: 12/9/2026.
- Postal code
- 72701-5013
- Report date
- Sep 16, 2026
- Product type
- Drugs
- Recall number
- D-0864-2026
- Classification
- Class II
- Recalling firm
- OurPharma LLC
- Product quantity
- 1,610 bags
- Reason for recall
- 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).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide within the U.S
- Recall initiation date
- Sep 3, 2026
- Initial firm notification
- Letter
- Center classification date
- Sep 21, 2026