Class II · Moderate risk
fentaNYL Citrate
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).
FentaNYL Citrate 2.5 mg/50 mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Underfilled units.
Cause type: Other
Recalls whose stated reason does not fall into the categories above. See the recall's own reason text for the specifics. All other recalls.
What was recalled
FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01
Affected NDC
73013-0001-01
Compare with the code on your package — it is the most precise check available.
Drug: Fentanyl
- Recalling firm
- OurPharma LLC
- NDC code
- 73013-001-01
- Origin
- AR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0078-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fentanyl recalls
See all
Class II · Moderate risk
fentaNYL Citrate
Subpotent Drug
Class II · Moderate risk
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution
cGMP deviations.
Other recalls by OurPharma LLC
All 2022 recalls
Class II · Moderate risk
fentaNYL Citrate
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).
Class III · Low risk
HYDROmorphone Hydrochloride 50mg/50mL
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Class III · Low risk
FentaNYL Citrate 2.5mg/50mL
Short Fill: Underfilled units.
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