Class II · Moderate risk
10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
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
10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
Fentanyl Citrate 50 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 10 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a…
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL Intravia bag
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium…
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate injection
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 50 mcg/ml injection
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL…
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 10 mg/ml/Fentanyl Citrate 0.15 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl PF 50 mL
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class I · High risk
fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection
Subpotent Drug
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