Safecor Health Fluphenazine HCl Oral Elixir
Fluphenazine HCl Elixir failed stability specifications.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
2 photos
What happened
Safecor Health, LLC of Woburn, Massachusetts is recalling Fluphenazine HCl Elixir and related oral products because they failed stability specifications. The products, including Fluphenazine HCl Elixir, USP, and Fluphenazine HCl Oral Solution (Concentrate), USP, were distributed nationwide in the USA. The recall began on August 13, 2026, and was added to the FDA's Enforcement Report on September 14, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
Fluphenazine HCl Oral Elixir, USP
- Strength
- 2.5 mg
- Lot
- 26160463
- 25430188
- 25440715
- 25501160
- 26021054
- 26130635
- 26200964
- Strength
- 5 mg
- Lot
- 26220866
- 25321477
- 25471651
- 25500133
- 26161398
- 26170946
- 26240033
- 25500134
- Strength
- 5 mg
- Lot
- 25330169
- 25340107
- 25370044
- 25391430
- 25411035
- 25461036
- 25450206
- 25521269
- 26030426
- 26071765
- 26111371
- 26121435
- 26141209
- 26151211
- 26170561
- 26171144
- 26210307
- 26241285
- 26191168
- 26231182
Fluphenazine HCl Elixir, USP
- Strength
- 15 mg
- UPC
- 26080483
- 25310327
- 25330414
- 25430340
- Strength
- 5 mg
- UPC
- 25330169
- 25340107
- 25370044
- 25391430
- 25411035
- 25461036
- 25450206
- 25521269
- 26030426
- 26071765
- 26111371
- 26121435
- 26141209
- 26151211
- 26170561
- 26171144
- 26191168
- 26210307
- 26231182
- 26241285
- Strength
- 5 mg
- UPC
- 26220866
- 25321477
- 25471651
- 25500133
- 26161398
- 26170946
- 26240033
- Strength
- 2.5 mg
- UPC
- 26160463
- 25430188
- 25440715
- 25501160
- 26021054
- 26130635
- 26200964
- Strength
- 20 mg
- UPC
- 25330415
- 25340169
- 25380387
- 25410936
- 25450649
- 25471328
- 26120385
- 26141494
- 26170183
- 26220497
- Strength
- 10 mg
- UPC
- 25421159
- 25431644
- 25471687
- 25510930
- 26130247
- 25450648
- 26061716
- 26120384
- 26141493
- 26190055
- 26231530
Fluphenazine HCl Oral Solution (Concentrate), USP
- Strength
- 10 mg
- Lot
- 25421159
- 25431644
- 25471687
- 25510930
- 26130247
- 25450648
- 26061716
- 26120384
- 26141493
- 26190055
- 26231530
- 25301703
- Strength
- 15 mg
- Lot
- 26080483
- 25310327
- 25330414
- 25430340
- 25280878
Fluphenazine HCl Oral Solution (Concentrate) , USP
- Strength
- 20 mg
- Lot
- 25330415
- 25340169
- 25380387
- 25410936
- 25450649
- 25471328
- 26120385
- 26141494
- 26170183
- 26220497
From the FDA notice
NDC: 00121-0654-16
Details
- Company began the recall
- Sold in
Nationwide in the USA.
- Event ID
- 99654
- Recall numbers
- D-0841-2026 to D-0846-2026
- Company
- Safecor Health, LLCWoburn, Massachusetts
- Hazard
- Failed specifications
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
