Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Fentanyl Citrate Injection Recalled by Akorn Inc Due to Failed impurities/degradation specification: Out-of-Specification result for total impurity...
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
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02
Quantity: 15,170 ampules
Why Was This Recalled?
Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Akorn Inc
Akorn Inc has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report