Class II · Moderate risk
Sufenta (Sufentanil Citrate Injection, USP)
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Is Sufentanil recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Sufentanil (23 total). Check the affected lots below.
Most common reason: Sterility / contamination (15 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sufentanil. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Sufentanil recalls on record
none so far in 2026; 23 on record, newest first
Class II · Moderate risk
Sufentanil Citrate Injection
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Class I · High risk
Hydromorphone Hcl-Bupivacaine Hcl-Sufentanil Pf…
Non-Sterility
Class I · High risk
Class II · Moderate risk
SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
SUFENTANIL 150MCG/ML INJ in 20 mL syringe Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
All sterile drug preparations remaining within expiry prepared…
Lack of sterility assurance.
Class II · Moderate risk
Sufentanil Citrate all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
1 mcg/mL Sufentanil 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
0.5 mcg/mL Sufentanil 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
0.4 mcg/mL Sufentanil 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
0.4 mcg/mL Sufentanil 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
Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium…
Lack of Assurance of Sterility
Class II · Moderate risk
Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Sufentanil Cit 200 mcg/ml/Clonidine HCL 1600 mcg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Sufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Sufentanil 50 mcg/ml + Bupivacaine 0.25 mg/ml Solution
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Sufentanil 50 mcg/ml Solution
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Sufentanil 45 mcg/ml + Bupivacaine 5 mg/ml Solution
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Bupivacaine/Sufentanil
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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