Reumo Flex caplets recalled for undeclared diclofenac content nationwide
Reumo Flex caplets packaged in 30-count boxes are being recalled because they contain undeclared diclofenac and were marketed without FDA approval. The product was distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I designation requires a minimum severity of 4 per the rubric. The product contains an undeclared active pharmaceutical ingredient and was marketed without FDA approval. No illnesses or injuries have been reported in the source material.
Plain-English summary
Reumo Flex caplets are being recalled because they contain undeclared diclofenac, a prescription nonsteroidal anti-inflammatory drug (NSAID). The product was marketed and distributed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), which is required for all drugs sold in the United States. Reumo Flex caplets are packaged in 30-count boxes, manufactured by Grupo Yepenza de Mexico, SA de CV, with UPC 7 502214 014598.
This recall affects Reumo Flex caplets with all lot numbers and expiration date 10/20/2024 distributed nationwide. Consumers who purchased this product should stop using it immediately and consult a healthcare provider if they have already used the product.
The presence of an unapproved, undeclared prescription medication in a product marketed as a botanical supplement violates federal drug regulations. Consumers who took this product were exposed to a medication without the medical oversight required for safe use of this drug.
The recalled product
- 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
- Manufacturer
- Botanical Be
- Category
- Drug — Dietary Supplement
- Hazard
- undeclared-diclofenac
- unapproved-drug
- mislabeling
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 10/20/2024
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27