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).
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9%…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
GMP Deviations: potential glass contamination
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20
Affected NDC
69374-0526-20
Compare with the code on your package — it is the most precise check available.
Drug: Fentanyl
- Recalling firm
- Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Origin
- SC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0149-2020 · 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 Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
All 2019 recalls
Class III · Low risk
PF-Succinylcholine Chloride Injection
Incorrect labeling: Incorrect or missing lot and/or exp date
Class II · Moderate risk
del Nido Cardioplegia Solution
Lack of Assurance of Sterility; bags have potential to leak
Class II · Moderate risk
Amino Acid Injection 50 g/1000 mL
Lack of Assurance of Sterility; bags have potential to leak
Class II · Moderate risk
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9%…
GMP Deviations: potential glass contamination
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.