The Recall Desk
HighFDA (Drugs)·D-0843-2023·Announced 2023-06-07

Fentanyl Citrate Injection Nationwide Recall Due to Manufacturing Compliance Deviations

Akorn, Inc. is recalling all lots of Fentanyl Citrate Injection nationwide due to manufacturing compliance deviations. The company was unable to complete required stability studies after ceasing operations.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall without reported illnesses or injuries. The hazard is unconfirmed product stability due to incomplete manufacturing studies, presenting theoretical risk to drug efficacy and safety.

Plain-English summary

Akorn, Inc. is recalling all lots of Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL) due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed nationwide in the United States and Puerto Rico. This is a Class II recall.

The firm went out of business and could no longer continue required stability studies for the product. Stability studies are conducted to ensure pharmaceuticals maintain their safety and efficacy throughout their intended shelf life.

Patients who are currently using this medication should consult with their healthcare provider regarding their treatment plan. Healthcare providers should review their inventory of affected lots and follow FDA guidance for managing this recall.

The recalled product

Product
Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Injectable
Hazard
  • stability-unconfirmed
  • cgmp-deviation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

Related recalls

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