Safecor Health, LLC Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Recall 2026
Safecor Health, LLCIssued August 13, 2026
Safecor Health, LLC 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 — recalled per FDA on 8/13/2026. Reason: Failed Stability Specifications.
What to do about this recall
- Agency
- FDA
- Issued
- Aug 13, 2026
- Brand
- Safecor Health, LLC
- Distribution
- 1 states
- Lots affected
- 20
Steps to take for this recall
Stop using it
Take it out of rotation. Don't consume, wear, or operate.
Verify the match
Compare lot numbers, UPCs, and dates against your product.
Return or dispose
Follow the manufacturer's instructions to refund or safely dispose.
What's recalled
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
Why it was recalled
Failed Stability Specifications
Affected products & lot numbers20 lots called out
Affected Lot Numbers
Check your product label — do not use if your lot number appears below.
| Lot Number |
|---|
| 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 Lot #:26111371 |
| Exp :03/24/2027 Lot #:26121435 |
| Exp :03/31/2027 Lot #:26141209 |
| Exp :04/07/2027 Lot #:26151211 |
| Exp :04/13/2027 Lot #:26170561 |
| Exp :04/23/2027 Lot #:26171144 |
| Exp :04/24/2027 Lot #:26191168 |
| Exp :05/08/2027 Lot #:26210307 |
| Exp :05/21/2027 Lot #:26231182 |
| Exp :06/04/2027 Lot #:26241285 |
Where was it sold1 state
Nationwide in the USA.
More recalls like this8 related — by brand, contaminant, and category
Other Safecor Health, LLC recalls
- Safecor Health, LLC Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Recall 20262026
- Safecor Health, LLC Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Recall 20262026
- Safecor Health, LLC Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Recall 20262026
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Frequently asked questions
Is the Safecor Health, LLC recall still active?
Yes, this recall is currently active as of August 13, 2026. Do not use or consume the affected product.
What lot numbers are affected?
Affected lot numbers: 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 Lot #:26111371, Exp :03/24/2027 Lot #:26121435, Exp :03/31/2027 Lot #:26141209, Exp :04/07/2027 Lot #:26151211, Exp :04/13/2027 Lot #:26170561, Exp :04/23/2027 Lot #:26171144, Exp :04/24/2027 Lot #:26191168, Exp :05/08/2027 Lot #:26210307, Exp :05/21/2027 Lot #:26231182, Exp :06/04/2027 Lot #:26241285. Check the label on your product.
What should I do if I have the recalled Safecor Health, LLC?
Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.