Safecor Health, LLC recalls Fluphenazine HCl Elixir
- Recalling company
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Aug 13, 2026
- Reported
- Sep 23, 2026
- Distribution
- Nationwide in the USA.
- Status
- Ongoing
- Quantity
- N/A
- Lot / codes
- 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
- Company location
- Woburn, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0841-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0841-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.