Reported Sep 23, 2026 · Ongoing
Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use…
Safecor Health, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Safecor Health, LLC · 317 New Boston St · Woburn, MA · 01801-6231
Is this the product you have?
- Fluphenazine HCl Elixir, USP, 20 mg per 4 mL
- Delivers10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only
- Pkg bySafecor Health, Woburn, MA 01801
- NDC00121-0653-04
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 Lot#:25330415 2 Exp :08/26/2026 Lot#:25340169 3 Exp :09/05/2026 Lot#:25380387 4 Exp :10/17/2026 Lot#:25410936 5 Exp :11/13/2026 Lot#:25450649 6 Exp :11/30/2026 Lot#:25471328 7 Exp :01/05/2027 Lot#:26120385 8 Exp :03/27/2027 Lot#:26141494 9 Exp :04/07/2027 Lot#:26170183 10 Exp :04/21/2027 Lot#:26220497 11 Exp :05/28/2027
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Stability Specifications
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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