Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Haloperidol Decanoate Injection Recalled by Mylan Institutional LLC Due to Lack of Assurance of Sterility; due to leaking...
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 Mylan Institutional LLC directly.
Affected Products
Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103
Quantity: 2,523 cartons (25,936 vials)
Why Was This Recalled?
Lack of Assurance of Sterility; due to leaking vials
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mylan Institutional LLC
Mylan Institutional LLC has 15 total recalls tracked by RecallDetector.
Related Recalls
Icosapent Ethyl Capsules Recalled by Zydus Pharmaceuticals (USA) Inc Due to Failed Tablet/Capsule specifications: Red dots inside capsule and...
Zydus Pharmaceuticals (USA) Inc · March 9, 2026
Product label: Temozolomide Capsules Recalled by Rising Pharma Holding, Inc. Due to Failed Impurities/Degradation Specifications: An out-of-specification result observed during...
Rising Pharma Holding, Inc. · March 3, 2026
Semaglutide Inj. Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Tirzepatide Inj Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Tirzepatide Inj Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report