drugs MODERATE Updated 2026-09-23

Safecor Health, LLC recalls Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 m

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Recalled Product

Fluphenazine HCl Elixir, USP, 10 mg per 2 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

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Hazard / Issue

Failed Stability Specifications

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot#:25421159; Exp :10/21/2026 Lot#:25431644; Exp :11/03/2026 Lot#:25471687; Exp :12/02/2026 Lot#:25510930; Exp :01/05/2027 Lot#:26130247; Exp :04/17/2027 Lot#:25450648; Exp :11/30/2026 Lot#:26061716; Exp :02/28/2027 Lot#:26120384; Exp :03/27/2027 Lot#:26141493; Exp :04/07/2027 Lot#:26190055; Exp :05/04/2027 Lot#:26231530; Exp :06/05/2027

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.

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