Fluphenazine HCl Elixir Recall: Safecor Health Lot 26160463
Announced 2026-09-23 · FDA
Fluphenazine HCl Elixir, USP, 15 mg per 3 mL (delivers 10 mL) is recalled nationwide for failed stability specifications. The product is Rx Only, with 14% alcohol by volume, packaged by Safecor Health, Woburn, MA 01801, NDC 00121-0654-16. The recall includes multiple lots with expiration dates.
| Brand | Safecor Health, LLC |
|---|---|
| Product | 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 |
| Reason | Failed Stability Specifications |
| Severity | moderate |
| Units affected | N/A |
| Distribution | Nationwide in the USA. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use recalled product.
- Check your bottle’s lot number; if it matches the recalled Lot 26160463, discontinue use and contact your healthcare provider or pharmacist.
- Return the product to the place of purchase or follow local disposal guidelines.
How to identify the recalled item
| Lot / date codes | 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 |
|---|---|
| Lot / date codes | Lot#:26080483; Exp :03/13/2027 Lot#:25310327; Exp :08/12/2026 Lot#:25330414; Exp :08/26/2026 Lot#:25430340; Exp :11/22/2026 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other Safecor Health, LLC recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.