# FDA recall D-0225-2024

> **Botanical Be** · Class I · drug recall initiated 2023-10-20.

## Product

Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598

## Reason for recall

Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0225-2024
- **Recalling firm:** Botanical Be
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-10-20
- **Report date:** 2023-12-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0225-2024

## Citation

> AI Analytics. FDA recall D-0225-2024. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/D-0225-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*