Reported Sep 23, 2026 · Ongoing
Fluphenazine HCl Elixir, USP, 5 mg per 1 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 1 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
21 of 21 products
Products covered by this recall # Product as published 1 Lot #:25330169 2 Exp :08/25/2026 Lot #:25340107 3 Exp :09/04/2026 Lot #:25370044 4 Exp :09/30/2026 Lot #:25391430 5 Exp :10/30/2026 Lot #:25411035 6 Exp :11/13/2026 Lot #:25461036 7 Exp :12/12/2026 Lot #:25450206 8 Exp :12/12/2026 Lot #:25521269 9 Exp :02/03/2027 Lot #:26030426 10 Exp :02/09/2027 Lot #:26071765 11 Exp :03/11/2027 Lot #:26111371 12 Exp :03/24/2027 Lot #:26121435 13 Exp :03/31/2027 Lot #:26141209 14 Exp :04/07/2027 Lot #:26151211 15 Exp :04/13/2027 Lot #:26170561 16 Exp :04/23/2027 Lot #:26171144 17 Exp :04/24/2027 Lot #:26191168 18 Exp :05/08/2027 Lot #:26210307 19 Exp :05/21/2027 Lot #:26231182 20 Exp :06/04/2027 Lot #:26241285
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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