CLASS II Drug recall · Reported 21 Dec 2022 · FDA Enforcement Report
FentaNYL Citrate 2.5 mg/ (50mcg/ml) Injection Solution recalled
OurPharma is recalling FentaNYL Citrate 2.5 mg/ (50mcg/ml) Injection Solution, Preservative Free, Single Use, distributed in Missouri. The recall was initiated on 29 Nov 2022 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-0078-2023
- FDA event ID
- 91229
- Recalling firm
- OurPharma, Fayetteville, AR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Nov 2022
- FDA classified
- 9 Dec 2022
- Reported
- 21 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 29 Nov 2022 | Recall initiated by company | |
| 9 Dec 2022 | Classified by FDA | +10 days |
| 21 Dec 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Underfilled units.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
MO
Questions about this recall
Why was it recalled?
Underfilled units.
Which lots are affected?
Lots: 100122060007 Exp. 12/17/2022; 100122060008 Exp. 12/18/2022; 100122070002 Exp. 01/09/2023.
Where was it sold?
MO
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 26 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 II | fentaNYL Citrate, 1,000 mcg recalled by OurPharma | OurPharma | Other | Nationwide |
| 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 |
Other Fentanyl recalls
All 248| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL Citrate, 1,000 mcg recalled by OurPharma | OurPharma | Other | Nationwide |
| Drug | CLASS II | fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalled | IntegraDose Compounding Services | Potency & Assay | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution recalled by Wells Pharma of Houston | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, CII recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, Cii recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |