Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Asenapine Sublingual Tablets Recalled by SigmaPharm Laboratories LLC Due to Incorrect Product Formulation; product was manufactured with the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SigmaPharm Laboratories LLC directly.
Affected Products
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
Quantity: 6266 bottles
Why Was This Recalled?
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SigmaPharm Laboratories LLC
SigmaPharm Laboratories LLC has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report