Class II · Moderate risk
fentaNYL 1500 mcg/30 mL
Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
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 Injection
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Class III · Low risk
Fentanyl Transdermal System
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Actiq (oral transmucosal fentanyl citrate)
Failed Dissolution Specification; during stability testing
Class II · Moderate risk
Fentanyl Transdermal System
Subpotent; some patches may not contain fentanyl gel
Class II · Moderate risk
Fentanyl
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Bupivacaine/Fentanyl in Sodium Chloride 0.9% P. F. 30 Mg/200 Mcg/Ml Intrathecal 40 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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