Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fentanyl Citrate Inj. Recalled by Pfizer Inc. Due to Lack of Assurance of Sterility; potential loose metal...
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 Pfizer Inc. directly.
Affected Products
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12
Quantity: 19,144 vials
Why Was This Recalled?
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Where Was This Sold?
United States including Puerto Rico
About Pfizer Inc.
Pfizer Inc. has 114 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report