CLASS II ONGOING Drug recall · Reported 16 Sep 2026 · FDA Enforcement Report
fentaNYL Citrate, 1,000 mcg recalled by OurPharma
OurPharma is recalling fentaNYL Citrate, 1,000 mcg/ (10mcg/mL) Injection solution in, 0.9% NaCl, OurPharma LLC, distributed nationwide in the US. The recall was initiated on 3 Sep 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0864-2026
- FDA event ID
- 99837
- Recalling firm
- OurPharma, Fayetteville, AR
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Sep 2026
- FDA classified
- 21 Sep 2026
- Reported
- 16 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 3 Sep 2026 | Recall initiated by company | |
| 16 Sep 2026 | Published in enforcement report | +13 days |
| 21 Sep 2026 | Classified by FDA | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the U.S
Questions about this recall
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).
Which lots are affected?
Lot #: 101301260605, BUD: 12/9/2026.
Where was it sold?
Nationwide within the U.S
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from OurPharma
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | HYDROmorphone Hydrochloride 50mg/ (1mg/mL) recalled by OurPharma | OurPharma | Potency & Assay | Nationwide |
| Drug | CLASS III | FentaNYL Citrate 2.5mg/ (50mcg/mL) Injection Solution recalled | OurPharma | Packaging Defects | IL, MO |
| Drug | CLASS II | FentaNYL Citrate 2.5 mg/ (50mcg/ml) Injection Solution recalled | OurPharma | Packaging Defects | MO |