Reported Sep 23, 2026 · Ongoing
Fluphenazine HCl Elixir, USP, 10 mg per 2 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, 10 mg per 2 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
12 of 12 products
Products covered by this recall # Product as published 1 Lot#:25421159 2 Exp :10/21/2026 Lot#:25431644 3 Exp :11/03/2026 Lot#:25471687 4 Exp :12/02/2026 Lot#:25510930 5 Exp :01/05/2027 Lot#:26130247 6 Exp :04/17/2027 Lot#:25450648 7 Exp :11/30/2026 Lot#:26061716 8 Exp :02/28/2027 Lot#:26120384 9 Exp :03/27/2027 Lot#:26141493 10 Exp :04/07/2027 Lot#:26190055 11 Exp :05/04/2027 Lot#:26231530 12 Exp :06/05/2027
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.
Free recall alerts
Get alerted about new Safecor Health, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.