Reported Sep 23, 2026 · Ongoing
Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 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, 2.5 mg per 5 mL
- Delivers5 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#26160463
- Exp04/20/2027 Lot#25430188
- Exp11/26/2026 Lot#25440715
- Exp12/9/2026 Lot#25501160
- Exp01/21/2027 Lot#26021054
- Exp02/5/2027 Lot#26130635
- Exp04/3/2027 Lot#26200964
- Exp05/13/2027
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.
Want the full recall guide?
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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