Class II Recall

Safecor Health, LLC

Product
Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
Reason
Failed Stability Specifications
Classification
Class II
Status
Ongoing
Lot
Lot#26160463; Exp :04/20/2027 Lot#25430188; Exp :11/26/2026 Lot#25440715; Exp :12/9/2026 Lot#25501160; Exp :01/21/2027 Lot#26021054; Exp :02/5/2027 Lot#26130635; Exp :04/3/2027 Lot#26200964; Exp :05/13/2027
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Safecor Health, LLC — Class II Recall | MedicineWatch US