Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Benztropine Mesylate Injection Recalled by Fresenius Kabi USA, LLC Due to Presence of particulate matter: characterized as thin colorless...
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
Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-970-02; and b) Manufactured in the USA for Nexus Pharmaceuticals Inc., Vernon Hills, IL 60061, NDC 14789-300-02
Quantity: 65110 vials
Why Was This Recalled?
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC has 67 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report