D-0846-2026 Class II Ongoing
FDA drug recall D-0846-2026 was initiated by Safecor Health, LLC on August 13, 2026 and is designated Class II. Reason for recall: Failed Stability Specifications The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- September 23, 2026
- Initiation Date
- August 13, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
Reason for Recall
Failed Stability Specifications
Distribution Pattern
Nationwide in the USA.
Code Information
Lot#:25330415; Exp :08/26/2026 Lot#:25340169; Exp :09/05/2026 Lot#:25380387; Exp :10/17/2026 Lot#:25410936; Exp :11/13/2026 Lot#:25450649; Exp :11/30/2026 Lot#:25471328; Exp :01/05/2027 Lot#:26120385; Exp :03/27/2027 Lot#:26141494; Exp :04/07/2027 Lot#:26170183; Exp :04/21/2027 Lot#:26220497; Exp :05/28/2027