# FDA recall D-0844-2026

> **Safecor Health, LLC** · Class II · drug recall initiated 2026-08-13.

## Product

Fluphenazine HCl Elixir, USP, 10 mg per 2 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

## Reason for recall

Failed Stability Specifications

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0844-2026
- **Recalling firm:** Safecor Health, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-08-13
- **Report date:** 2026-09-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Woburn, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0844-2026

## Citation

> MORVS. FDA recall D-0844-2026. Retrieved 2026-10-15 from https://api.morvs.ai/recall/D-0844-2026. Source: US FDA. Licensed CC0.

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