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).
Is Fentanyl recalled?
Yes — there is an active recall. 22 ongoing FDA recalls mention Fentanyl (357 total). Check the affected lots below.
Most common reason: Sterility / contamination (197 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fentanyl. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Fentanyl recalls in 2026
7 initiated in 2026, 357 in total — newest first
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.
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.
Class III · Low risk
FentaNYL Citrate PF
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
Fentanyl citrate
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Class II · Moderate risk
FentaNYL 500mcg
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL Citrate PF 200 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL Citrate PF 200 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL Citrate PF 200 mcg/100 mL
Lack of Assurance of Sterility
Class I · High risk
Fentanyl Transdermal System CII
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Class II · Moderate risk
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL
Lack of Assurance of Sterility
Class III · Low risk
Fentanyl 1000mcg/100mL
Labeling: Wrong Barcode
Class II · Moderate risk
fentaNYL Citrate 2
Lack of Assurance of Sterility: leaking bags
Class II · Moderate risk
FentaNYL citrate
Lack of Assurance of Sterility: Firm did not perform process validation.
Class I · High risk
FentaNYL citrate PF
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk
FentaNYL citrate PF
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class II · Moderate risk
fentaNYL 2
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 1
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 500 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 500 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 100 mcg/50 mL
Lack of Assurance of Sterility
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