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
Asenapine Sublingual Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Cause type: Other
Recalls whose stated reason does not fall into the categories above. See the recall's own reason text for the specifics. All other recalls.
What was recalled
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
Affected NDC
42794-0017-10
Compare with the code on your package — it is the most precise check available.
Drug: Asenapine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Asenapine NDC 42794-0017 |
10 mg/1 | Tablet Sublingual |
Sigmapharm Laboratories, LLC | Rx |
- Recalling firm
- SigmaPharm Laboratories LLC
- NDC code
- 42794-017-10
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0380-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Asenapine recalls
See all
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
Other recalls by SigmaPharm Laboratories LLC
All 2021 recalls
Class II · Moderate risk
Sodium Phenylbutyrate Powder
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Class II · Moderate risk
Sodium Phenylbutyrate POWDER
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
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
Liothyronine Sodium Tablets
Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.
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