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

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

Recall #: D-0225-2024
Initiated: October 20, 2023

Compiled from official public sources by the publisher. · Updated September 2026

Botanical Be recalled Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico,… - a critical-severity action.

Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico,… was recalled by Botanical Be in December 6, 2023. Reason: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.. Check the official notice for the remedy. Verify recall #D-0225-2024 with the FDA Drug before acting.

The recall

Botanical Be issued this critical-severity FDA Drug recall-Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac..

Critical
severity level: Class I
classification: December 6, 2023
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0225-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

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

Reason for recall

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

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Critical (Class I)
Status	Ongoing
Recall number	D-0225-2024
Date reported	December 6, 2023
Date initiated	October 20, 2023
Recalling firm	Botanical Be
Firm location	El Paso, TX
Affected scope	Not disclosed
Distribution	USA Nationwide

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-0225-2024) and product description against the item you own. Search the archive
Confirm the current status with FDA Drug before acting, recall details can be updated.
This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

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. Recalled by Botanical Be.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on December 6, 2023. Severity: Critical. Recall number: D-0225-2024.

Where was the recalled product distributed? ▼

Distribution: USA Nationwide.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Critical), closest by report date among other firms and states.

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Similar Drugs & Medications · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: FDA Drug, reported December 6, 2023. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026