Home / Recalls / Safecor Health, LLC / D-0845-2026

D-0845-2026 Class II Ongoing

Recalled by Safecor Health, LLC — Woburn, MA

FDA drug recall D-0845-2026 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, 15 mg per 3 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#:26080483; Exp :03/13/2027 Lot#:25310327; Exp :08/12/2026 Lot#:25330414; Exp :08/26/2026 Lot#:25430340; Exp :11/22/2026

Other recalls by Safecor Health, LLC

D-0843-2026 Class II — Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, (August 13, 2026)
D-0846-2026 Class II — Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, (August 13, 2026)
D-0842-2026 Class II — Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, (August 13, 2026)
D-0844-2026 Class II — Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, (August 13, 2026)
D-0841-2026 Class II — Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, (August 13, 2026)
D-0549-2026 Class II — Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contai (May 1, 2026)
D-0538-2026 Class II — Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are pac (April 30, 2026)
D-0214-2026 Class II — Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx (October 10, 2025)
D-0253-2025 Class II — Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, (February 17, 2025)
D-0251-2025 Class II — Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: (February 17, 2025)