OurPharma recall: FentaNYL Citrate
OurPharma LLC is recalling FentaNYL Citrate – 1,610 bags. The U.S. Food and Drug Administration published the recall on September 16, 2026; it began on September 3, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | FentaNYL Citrate |
| Brand | OurPharma |
| Company | OurPharma LLC |
| Type | Drugs |
| Classification | Class II |
| Recall date | September 3, 2026 |
| Published by FDA | September 16, 2026 |
| Quantity | 1,610 bags |
| Recall ID | 99837 |
Recalled products
- 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.
- FDA recall number
- D-0864-2026
- Codes, lots and dates
- Lot #: 101301260605, BUD: 12/9/2026.
- Quantity
- 1,610 bags
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99837
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Fayetteville, AR, United States
Why it was recalled
The reason the FDA lists: “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).”
Where it was sold
Nationwide. Distribution as the FDA records it: “Nationwide within the U.S”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99837, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other drug recalls
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|---|---|---|---|
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| Oct 7, 2026 | Apotex recall: Paroxetine Extended-Release TabletsDrugs | Failed dissolution specifications. Serious | FDA Class II |
| Oct 7, 2026 | TerSera Therapeutics recall: ZoladexDrugs · 296 cartons | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II |
| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is OurPharma FentaNYL Citrate recalled?
Yes. OurPharma LLC recalled it on September 3, 2026; FDA published it September 16, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it 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).
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.