CLASS I ONGOING Drug recall · Reported 6 Dec 2023 · FDA Enforcement Report
Kuka Flex Forte caplets recalled by Botanical Be
Botanical Be is recalling Kuka Flex Forte caplets, distributed nationwide in the US. The recall was initiated on 20 Oct 2023 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0226-2024
- FDA event ID
- 93257
- Recalling firm
- Botanical Be, El Paso, TX
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 20 Oct 2023
- FDA classified
- 12 Jan 2024
- Reported
- 6 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
Timeline
| 20 Oct 2023 | Recall initiated by company | |
| 6 Dec 2023 | Published in enforcement report | +47 days |
| 12 Jan 2024 | Classified by FDA | +37 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Product as listed by the FDA
Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265
Where it was distributed
USA Nationwide
Questions about this recall
Is Kuka Flex Forte caplets recalled?
Yes. Botanical Be recalled Kuka Flex Forte caplets on 20 Oct 2023. The recall is Class I and its status is Ongoing. Recall number D-0226-2024.
Why was it recalled?
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Which lots are affected?
All lots, exp 12/12/2024
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Botanical Be
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Reumo Flex caplets recalled by Botanical Be | Botanical Be | Labeling Errors | Nationwide |
| Drug | CLASS I | Artri King Reforzado con Origa y Omega recalled by Botanical Be | Botanical Be | Labeling Errors | Nationwide |