Class III · Low risk
Asenapine Sublingual Tablets
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Is Asenapine recalled?
Not under an active recall.
Asenapine was recalled 3 times in the past — all now closed. Most recent: Apr 19, 2021.
Most common reason: Other (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Asenapine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Asenapine recalls on record
none so far in 2026; 3 on record, newest first
Class III · Low risk
Asenapine Sublingual Tablets
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class II · Moderate risk
Saphris 10 mg
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
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