D-0225-2024Class I

Botanical Be

Recalling firm

Botanical Be

Product type

Drug

Status

Ongoing

Report date

2023-12-06

Distribution

USA Nationwide

Firm state

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

Reason for recall

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

Product description

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

Code / lot info

All lots, exp 10/20/2024

Other recalls SPEQ maps to Documentation & Change Control

2026-07-22Class IIDaavlin Distributing Company 2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class IIChocolate Bar Holdings LLC

See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.