FDA Drug recall D-0225-2024
Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalup…
- FDA Drug
- Class I
- ongoing
- Published 2023-12-06
On 2023-12-06 the FDA classified a Class I recall of Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalup… by Botanical Be, citing marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0225-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-10-20 |
| Published | 2023-12-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Botanical Be |
| Distribution | US |
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
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Identifiers
| upc | 7502214014598 |
|---|---|
| code_info | All lots, exp 10/20/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0225-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.