123Herbals LLC, through Anthony Trinh, announced the recall, and the FDA provided an update shortly afterward.
The recall applies to all lots of Silintan capsules, a dietary supplement promoted for easing joint and body aches.
The product was sold online nationwide through 123herbals.com.
The company said it is contacting distributors and customers by email and organizing returns of all recalled items.
Why the Product Was Recalled
FDA testing determined that the product contains meloxicam.
Meloxicam is an approved nonsteroidal anti-inflammatory drug, or NSAID, used to treat osteoarthritis pain, but it is not permitted in dietary supplements.
Because of this ingredient, Silintan capsules are treated as an unapproved new drug whose safety and effectiveness have not been established.
The company warned that meloxicam exposure above the recommended maximum daily dose of 15 mg may lead to serious, potentially life-threatening events such as blood clots, heart attack, and stroke.
Other possible hazards include allergic reactions, gastrointestinal bleeding, ulceration, perforation, acute kidney injury, and harmful drug interactions, especially for people taking blood thinners or other NSAIDs.
So far, no adverse events linked to the recall have been reported.
Products Included in the Recall
Silintan capsules
Dietary supplement capsules marketed for relief of joint and body aches
Packaged in blue-labeled plastic bottles containing 25 capsules
All lots that are still within expiration are part of the recall.
How to Recognize the Recalled Product
Consumers should look for Silintan capsules sold in blue-labeled plastic bottles containing 25 capsules.
The recall includes all lot numbers still within expiration.
No UPC, best-by date, or establishment number was provided in the notice.
The FDA notice also includes product label images to help with identification.
For more details about this recall, visit the FDA notice at the provided link.
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