Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
HALOPERIDOL DECANOATE INJECTION Recalled by Fresenius Kabi USA LLC Due to Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three...
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 Fresenius Kabi USA LLC directly.
Affected Products
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
Quantity: 216,517 vials
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Kabi USA LLC
Fresenius Kabi USA LLC has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report