Class I · High risk
fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection
Subpotent Drug
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 I · High risk
fentaNYL citrate in 0.9% Sodium Chloride Injection
Subpotent Drug
Class I · High risk
fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection
Subpotent Drug
Class I · High risk
fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection
Subpotent Drug
Class I · High risk
fentaNYL citrate in 0.9% Sodium Chloride Injection
Subpotent Drug
Class II · Moderate risk
Fentanyl Citrate
Stability data does not support expiry.
Class I · High risk
fentaNYL Citrate
Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.
Class II · Moderate risk
fentaNYL Citrate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
fentaNYL Citrate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
fentaNYL Citrate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
fentaNYL Citrate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
fentaNYL Citrate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
fentaNYL Citrate Injection
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
fentaNYL Citrate Injection
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
fentaNYL Citrate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
fentaNYL Citrate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
fentaNYL Citrate Injection
Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
fentaNYL Citrate Injection
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
Hydromorphone 80 mg/ml + Fentanyl 15
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Hydromorphone 80 mg/ml + Fentanyl 15
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Hydromorphone 70 mg/ml+Fentanyl 16
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Fentanyl 5
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Morphine 60 mg/ml + Fentanyl 12
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Morphine 50 mg/ml + Fentanyl 20
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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