Kuka Flex Forte caplets recalled for undeclared diclofenac and lack of FDA approval
Botanical Be is recalling Kuka Flex Forte caplets nationwide because they contain undeclared diclofenac and were marketed without required FDA approval. All lots expire 12/12/2024.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification for an unapproved drug product containing an undeclared pharmaceutical ingredient. Per agency guidance, FDA Class I recalls are never scored below 4, regardless of reported illness status.
Plain-English summary
Botanical Be is recalling Kuka Flex Forte caplets nationwide because the product was marketed without required FDA approval and contains the undeclared pharmaceutical ingredient diclofenac, a nonsteroidal anti-inflammatory drug (NSAID).
The recalled product is packaged in 30-count bottles with UPC 0736640810265. The product is affected in all lots with an expiration date of 12/12/2024. A total of 300 bottles have been distributed throughout the United States.
The presence of undeclared diclofenac poses a serious health risk. Consumers taking this product may unknowingly be exposed to an active pharmaceutical ingredient that could interact with other medications, create an overdose risk if they are also taking diclofenac separately, or cause adverse effects in patients with contraindications to NSAIDs such as those with cardiovascular or renal conditions. The unapproved status of the product means it has not undergone FDA review for safety or efficacy.
Consumers who have purchased this product should stop using it and consult their healthcare provider if they have any health concerns.
The recalled product
- Product
- Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265
- Manufacturer
- Botanical Be
- Category
- Drug
- Affected units
- 300
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All lots
- exp 12/12/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Botanical Be under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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