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 500mcg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25
Affected NDC
71170-0950-25
Compare with the code on your package — it is the most precise check available.
Drug: Fentanyl
- Recalling firm
- Apollo Care
- NDC code
- 71170-950-25
- Origin
- MO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0487-2023 · 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.
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 Apollo Care
All 2023 recalls
Class II · Moderate risk
SEMAGLUTIDE 20mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · Moderate risk
SEMAGLUTIDE 10mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · Moderate risk
SEMAGLUTIDE 7.5mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · Moderate risk
SEMAGLUTIDE 5mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
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