CLASS II ONGOING Drug recall · Reported 23 Sep 2026 · FDA Enforcement Report
Fluphenazine HCl Elixir, USP, 2.5 mg per, Delivers recalled
Safecor Health is recalling Fluphenazine HCl Elixir, USP, 2.5 mg per, Delivers:, Oral Elixir, PAI, Alcohol 14% by, distributed nationwide in the US. The recall was initiated on 13 Aug 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0841-2026
- FDA event ID
- 99654
- Recalling firm
- Safecor Health, Woburn, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Aug 2026
- FDA classified
- 14 Sep 2026
- Reported
- 23 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 13 Aug 2026 | Recall initiated by company | |
| 14 Sep 2026 | Classified by FDA | +32 days |
| 23 Sep 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Failed Stability Specifications
Which lots are affected?
Lot#26160463; Exp :04/20/2027 Lot#25430188; Exp :11/26/2026 Lot#25440715; Exp :12/9/2026 Lot#25501160; Exp :01/21/2027 Lot#26021054; Exp :02/5/2027 Lot#26130635; Exp :04/3/2027 Lot#26200964; Exp :05/13/2027
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 99654This product is part of a recall event; the main page for the event is Fluphenazine HCl Elixir, USP, 15 mg per, Delivers recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Fluphenazine HCl Elixir, USP, 15 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide | |
| CLASS II | Fluphenazine HCl Elixir, USP, 20 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide | |
| CLASS II | Fluphenazine HCl Elixir, USP, 10 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide | |
| CLASS II | Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide | |
| CLASS II | Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
More recalls from Safecor Health
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 10 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 20 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 15 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
Other Fluphenazine recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 10 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 20 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 15 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |