Lower risk Drug recall · FDA · Published April 19, 2021

SigmaPharm Asenapine Tablets Recall: Incorrect Flavoring Agent

SigmaPharm recalls 5 mg Asenapine Sublingual Tablets due to incorrect flavoring agent. Affected lots expire AUG 2022. No action needed for safe use.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0379-2021Drug SigmaPharm ›

Lower-risk recall

Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent

Take action

Contact the company

Recalling firmSigmaPharm Laboratories LLC3375 Progress Dr · Bensalem, PA 19020-5801

✎ GovInfoNow plain-language explainer

SigmaPharm is recalling 5 mg Asenapine Sublingual Tablets because they were made with the wrong flavoring agent. This does not pose a safety risk to users and no action is required. Read more at govinfonow.com/recall/36206-sigmapharm-asenapine-tablets-recall-incorrect-flavoring-agent.

Source Summary by GovInfoNow · govinfonow.com/recall/36206-sigmapharm-asenapine-tablets-recall-incorrect-flavoring-agent · Updated October 4, 2026 · FDA enforcement record: FDA #D-0379-2021

Cite this page

“SigmaPharm Asenapine Tablets Recall: Incorrect Flavoring Agent.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36206-sigmapharm-asenapine-tablets-recall-incorrect-flavoring-agent. Based on FDA recall #D-0379-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0379-2021%22&limit=1).

The FDA announced on April 19, 2021, that SigmaPharm Laboratories LLC is recalling Asenapine Sublingual Tablets due to incorrect product formulation. The hazard involves the use of Art Cherry Flavoring instead of the specified Art Black Cherry Flavoring agent.

How to tell if you have it

Brand: SigmaPharm
Product: Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets
NDC: 42794-016-10
Lots: 2012501, 2012601, 2012701, & 2100701
Expiration Date: AUG 2022
Manufacturer: Sigmapharm Laboratories, LLC, Bensalem, PA, 19020

The hazard

The product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent. The recall is classified as Class III.

Context

GovInfoNow's records show SigmaPharm Laboratories LLC has 3 other recalls on record since April 22, 2014. Other recent recalls include the September 21, 2021, SigmaPharm Sodium Phenylbutyrate Powder Recall for impurity risk and the August 13, 2021, recall for failed impurities testing. Other recent recalls of similar products include the May 15, 2026, VistaPharm Cherry Sorbitol Activated Charcoal Recall and the June 4, 2026, Annora Pharma Lacosamide Tablets Recall.

How to tell if you have this one

Check your prescription label for the product name 'Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets'. Look for lot numbers 2012501, 2012601, 2012701, or 2100701 that expire in August 2022.

Brand
SigmaPharm
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class III
Status
Terminated
Distribution
Nationwide in the US
NDC
42794-016-22, 42794-016-08, 42794-016-10, 42794-017-22, 42794-017-08, 42794-017-10

Recall number	Product, codes & lots	Quantity
D-0379-2021	Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.; Lots # 2012501, 2012601 , 2012701, & 2100701, Exp. AUG 2022	6266 bottles
D-0380-2021	Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10; Lots # 2012801, 2012901, 2013001 & Lot 2100501, Exp AUG 2022; 2100101, Exp NOV 2022	8786 bottles

Based on the official FDA remedy

What to do — step by step

Check Your Product
Verify your tablets have the correct lot numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Apr 19, 2021Firm started the recall
May 14, 2021FDA classified it Class III
May 26, 2021Published in FDA’s Enforcement Report
Sep 26, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/36206-sigmapharm-asenapine-tablets-recall-incorrect-flavoring-agent">SigmaPharm Asenapine Tablets Recall: Incorrect Flavoring Agent (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0379-2021 (April 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0379-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.