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Class I: serious health riskOngoing

Botanical Be Kuka Flex Forte caplets Recall

Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonz…

Botanical Be · El Paso, TX

Risk level
Class I
Reported by FDA
Dec 6, 2023
Recall ID
D-0226-2024
Check your lot numberHow we source this data

Summary

Botanical Be recalled Kuka Flex Forte caplets starting Oct 20, 2023. The FDA classified it as Class I (serious health risk) and published enforcement report D-0226-2024 on Dec 6, 2023. Reason: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. Status: Ongoing.

Why it was recalled

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

Product description

Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265

Lot numbers, UPCs & expiration codes

All lots, exp 12/12/2024

Where it was sold

USA Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0226-2024
Classification
Class I
Status
Ongoing
Recall initiated
Oct 20, 2023
FDA report date
Dec 6, 2023
Quantity
300 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Botanical Be

Original FDA data

Every field from FDA enforcement report D-0226-2024, exactly as published.

Show all FDA fields
City
El Paso
State
TX
Status
Ongoing
Country
United States
Event ID
93257
Address
360 Jardin Bello
Code information
All lots, exp 12/12/2024
Postal code
79932-2357
Report date
Dec 6, 2023
Product type
Drugs
Recall number
D-0226-2024
Classification
Class I
Recalling firm
Botanical Be
Product quantity
300 bottles
Reason for recall
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265
Distribution pattern
USA Nationwide
Recall initiation date
Oct 20, 2023
Initial firm notification
Telephone
Center classification date
Jan 12, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0226-2024, published Dec 6, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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