Reported Sep 23, 2026 · Ongoing
Fluphenazine HCl Elixir, USP, 5 mg per 10 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, 5 mg per 10 mL
- Delivers10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only
- Pkg bySafecor Health, Woburn, MA 01801
- NDC00121-0654-16
- Lot codes and dates
- Lot#:26220866
- Exp06/18/2027 Lot#:25321477
- Exp0/18/2026 Lot#:25471651
- Exp12/01/2026 Lot#:25500133
- Exp12/19/2026 Lot#:26161398
- Exp12/31/2026 Lot#:26170946
- Exp05/15/2027 Lot#:26240033
- Exp05/31/2027
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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