Fluphenazine HCl Elixir recall
FDA recall D-0842-2026 · initiated Aug 13, 2026
Safecor Health, LLC recalled Fluphenazine HCl Elixir in Aug 2026 — an FDA Class II recall (D-0842-2026) because Failed Stability Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Stability Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- Product
- Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
- Recalling company
- Safecor Health, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- Aug 13, 2026
- FDA report date
- Sep 23, 2026
Frequently asked
- Was Fluphenazine HCl Elixir recalled?
- Safecor Health, LLC recalled Fluphenazine HCl Elixir in Aug 2026 — an FDA Class II recall (D-0842-2026) because Failed Stability Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Fluphenazine HCl Elixir recalled?
- Per the FDA enforcement record, the reason for recall D-0842-2026 was: Failed Stability Specifications
- Is a recalled Fluphenazine HCl Elixir dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Fluphenazine HCl Elixir are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — Lot #:25330169; Exp :08/25/2026 Lot #:25340107; Exp :09/04/2026 Lot #:25370044; Exp :09/30/2026 Lot #:25391430; Exp :10/30/2026 Lot #:25411035; Exp :11/13/2026 Lot #:25461036; Exp :12/12/2026 Lot #:25450206; Exp :12/12/2026 Lot #:25521269; Exp :02/03/2027 Lot #:26030426; Exp :02/09/2027 Lot #:26071765; Exp :03/11/2027 …. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0842-2026.