Class II · ModerateActive recall
Fluphenazine HCl Elixir
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot#:25330415; Exp :08/26/2026 Lot#:25340169; Exp :09/05/2026 Lot#:25380387; Exp :10/17/2026 Lot#:25410936; Exp :11/13/2026 Lot#:25450649; Exp :11/30/2026 Lot#:25471328; Exp :01/05/2027 Lot#:26120385; Exp :03/27/2027 Lot#:26141494; Exp :04/07/2027 Lot#:26170183; Exp :04/21/2027 Lot#:26220497; Exp :05/28/2027
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Stability Specifications
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Safecor Health, LLC |
| NDC | 00121-0653-04 |
Show the full FDA record
| Full product label | Fluphenazine HCl Elixir, USP, 20 mg per 4 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 firm | Safecor Health, LLC |
| Distribution | Nationwide in the USA. |
| Quantity | N/A |
| Recall initiated | 2026-08-13 |
| Report date | 2026-09-23 |
| Recall completed | — |
| Recall number | D-0846-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Woburn MA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.