CLASS II Drug recall · Reported 26 Feb 2025 · FDA Enforcement Report
fentaNYL Citrate In Sodium Chloride 1600mcg recalled
Fagron Compounding Services is recalling fentaNYL Citrate In Sodium Chloride 1600mcg/ (16 mcg per mL) CII, Single use IV, Fagron, distributed in Pennsylvania. The recall was initiated on 31 Jan 2025 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-0225-2025
- FDA event ID
- 96232
- Recalling firm
- Fagron Compounding Services, Wichita, KS
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 31 Jan 2025
- FDA classified
- 19 Feb 2025
- Reported
- 26 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 31 Jan 2025 | Recall initiated by company | |
| 19 Feb 2025 | Classified by FDA | +19 days |
| 26 Feb 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
Where it was distributed
Distributed in PA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot # C274-000040409, Exp 03/22/2025
Where was it sold?
Distributed in PA
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 Fagron Compounding Services
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vancomycin HCL added to, 0.9% Sodium Chloride Injection recalled | Fagron Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | norepinephrine Bitartrate,16mg per 0.9% Sodium Chloride recalled | Fagron Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | norepinephrine Bitartrate, 32mg per 0.9% Sodium Chloride recalled | Fagron Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | Vancomycin HCI added to, 0.9% Sodium Chloride Injection recalled | Fagron Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | Vancomycin HCI added to, 0.9% Sodium Chloride Injection recalled | Fagron Compounding Services | Sterility | Nationwide |
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 |