Class II · Moderate risk
Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and…
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
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 Active Pharmaceutical Ingredient
cGMP Deviations: Potential glass contamination
Class II · Moderate risk
Fentanyl 2mcg/Ml Bupivacaine 0.125% in Nacl 0.9% Sry C-Ii
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 0.05MG/ML INJ SOL
Lack of Assurance of Sterility
Class III · Low risk
Fentanyl Citrate Injection
Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
Class I · High risk
FENTANYL Transdermal System
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
Class II · Moderate risk
fentaNYL 2500 mcg/250 mL Injectable Solution
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL
Labeling: Incorrect expiration date.
Class II · Moderate risk
Fentanyl Citrate 2 mcg per mL
Sub-potent
Class II · Moderate risk
Fentanyl Citrate 2 mcg per mL
Sub-potent
Class II · Moderate risk
Fentanyl (10 mcg/mL)
Lack of assurance of sterility
Class II · Moderate risk
10 mcg/mL Fentanyl Citrate
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Class II · Moderate risk
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Class II · Moderate risk
Fentanyl (as citrate)
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Fentanyl (as citrate)
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
fentaNYL 2 mcg/mL
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
fentaNYL 5 mcg Citrate
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
fentaNYL 3 mcg/mL
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
fentaNYL (10 mcg per mL)
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL…
Lack of sterility assurance.
Class III · Low risk
Fentanyl Transdermal System
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Fentanyl Transdermal System. 75 mcg/h
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Fentanyl Transdermal System
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Fentanyl Transdermal System. 25 mcg/h
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
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