Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sufentanil Citrate Injection Recalled by Akorn, Inc. Due to Subpotent Drug: Out of specification for assay at...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Akorn, Inc. directly.
Affected Products
Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.
Quantity: 31,510 ampules
Why Was This Recalled?
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Akorn, Inc.
Akorn, Inc. has 176 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report