# FDA recall D-0541-2023

> **Wellness BioSciences** · Class II · drug recall initiated 2022-04-01.

## Product

CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays,  Wellness BioSciences Rx

## Reason for recall

Marketed Without an Approved NDA/ANDA

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0541-2023
- **Recalling firm:** Wellness BioSciences
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2022-04-01
- **Report date:** 2023-05-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Houston, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0541-2023

## Citation

> AI Analytics. FDA recall D-0541-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0541-2023. Source: US FDA. Licensed CC0.

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