Home / Recalls / Safecor Health, LLC / D-0842-2026

D-0842-2026 Class II Ongoing

Recalled by Safecor Health, LLC — Woburn, MA

FDA drug recall D-0842-2026 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, 5 mg per 1 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 #:25330169; Exp :08/25/2026 Lot #:25340107; Exp :09/04/2026 Lot #:25370044; Exp :09/30/2026 Lot #:25391430; Exp :10/30/2026 Lot #:25411035; Exp :11/13/2026 Lot #:25461036; Exp :12/12/2026 Lot #:25450206; Exp :12/12/2026 Lot #:25521269; Exp :02/03/2027 Lot #:26030426; Exp :02/09/2027 Lot #:26071765; Exp :03/11/2027 Lot #:26111371; Exp :03/24/2027 Lot #:26121435; Exp :03/31/2027 Lot #:26141209; Exp :04/07/2027 Lot #:26151211; Exp :04/13/2027 Lot #:26170561; Exp :04/23/2027 Lot #:26171144; Exp :04/24/2027 Lot #:26191168; Exp :05/08/2027 Lot #:26210307; Exp :05/21/2027 Lot #:26231182; Exp :06/04/2027 Lot #:26241285; Exp :06/15/2027

Other recalls by Safecor Health, LLC

  • 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-0845-2026 Class II — Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, (August 13, 2026)
  • 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-0844-2026 Class II — Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 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)

FDA data resources