Class II · Moderate risk
Fentanyl Citrate Injection in all strengths
Lack of sterility assurance.
Is Fentanyl recalled?
Yes — there is an active recall. 22 ongoing FDA recalls mention Fentanyl (357 total). Check the affected lots below.
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 on record
none so far in 2026; 357 on record, newest first
Class II · Moderate risk
Fentanyl Citrate in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
All sterile drug preparations remaining within expiry prepared…
Lack of sterility assurance.
Class II · Moderate risk
fentaNYL as citrate 2 mcg / mL
Lack Of Assurance Of Sterility.
Class II · Moderate risk
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125%
Lack Of Assurance Of Sterility.
Class II · Moderate risk
fentanyl citrate
Lack of Assurance of Sterility.
Class II · Moderate risk
fentaNYL citrate 1000 mcg
Lack of Assurance of Sterility.
Class II · Moderate risk
Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Class II · Moderate risk
Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Class II · Moderate risk
fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of assurance of sterility: Product bags leaking at seam.
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