Class II · Moderate risk
Fentanyl Citrate
Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
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
Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
Class II · Moderate risk
Fentanyl Citrate and Bupivacaine HCl all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Fentanyl Citrate with Ropivacaine HCl all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Fentanyl Citrate all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Fentanyl Citrate 2
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Fentanyl Citrate 1
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Fentanyl Citrate Injection
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Class II · Moderate risk
6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
6.66 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
5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
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
5 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
5 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.
Class II · Moderate risk
5 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
5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
4 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
4 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
4 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
3.5 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
3 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
3 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
3 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.
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