SigmaPharm Laboratories Asenapine Sublingual Tablets Recall

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

Product description

Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10

Lot numbers, UPCs & expiration codes

Lots # 2012801, 2012901, 2013001 & Lot 2100501, Exp AUG 2022; 2100101, Exp NOV 2022

Where it was sold

Nationwide in the US

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0380-2021
Classification: Class III
Status: Terminated
Recall initiated: Apr 19, 2021
FDA report date: May 26, 2021
Quantity: 8786 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: SigmaPharm Laboratories LLC

Original FDA data

Every field from FDA enforcement report D-0380-2021, exactly as published.

Show all FDA fields

City: Bensalem
State: PA
Status: Terminated
Country: United States
Event ID: 87748
Address: 3375 Progress Dr
Code information: Lots # 2012801, 2012901, 2013001 & Lot 2100501, Exp AUG 2022; 2100101, Exp NOV 2022
Postal code: 19020-5801
Report date: May 26, 2021
Product type: Drugs
Recall number: D-0380-2021
Classification: Class III
Recalling firm: SigmaPharm Laboratories LLC
Product quantity: 8786 bottles
Termination date: Sep 26, 2022
Reason for recall: Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Voluntary / mandated: Voluntary: Firm initiated
Product description: Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
Distribution pattern: Nationwide in the US
Recall initiation date: Apr 19, 2021
Initial firm notification: Letter
Center classification date: May 14, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0380-2021, published May 26, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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