CLASS III Drug recall · Reported 26 May 2021 · FDA Enforcement Report
Asenapine Sublingual Tablets, 10 mg recalled by SigmaPharm Laboratories
SigmaPharm Laboratories is recalling Asenapine Sublingual Tablets, 10 mg, distributed nationwide in the US. The recall was initiated on 19 Apr 2021 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0380-2021
- FDA event ID
- 87748
- Recalling firm
- SigmaPharm Laboratories, Bensalem, PA
- Brand
- Asenapine
- Manufacturer
- Sigmapharm Laboratories, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Apr 2021
- FDA classified
- 14 May 2021
- Reported
- 26 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 19 Apr 2021 | Recall initiated by company | |
| 14 May 2021 | Classified by FDA | +25 days |
| 26 May 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Which lots are affected?
Lots # 2012801, 2012901, 2013001 & Lot 2100501, Exp AUG 2022; 2100101, Exp NOV 2022
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 87748This product is part of a recall event; the main page for the event is Asenapine Sublingual Tablets, 5 mg recalled by SigmaPharm Laboratories.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Asenapine Sublingual Tablets, 5 mg recalled by SigmaPharm LaboratoriesAsenapine | SigmaPharm Laboratories | Packaging Defects | Nationwide |
More recalls from SigmaPharm Laboratories
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Phenylbutyrate Powder recalled by SigmaPharm Laboratories | SigmaPharm Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Sodium Phenylbutyrate Powder recalled by SigmaPharm Laboratories | SigmaPharm Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Asenapine Sublingual Tablets, 5 mg recalled by SigmaPharm LaboratoriesAsenapine | SigmaPharm Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Liothyronine Sodium Tablets, USP 5 mcg recalledLiothyronine Sodium | SigmaPharm Laboratories | Other | Nationwide |
Other Asenapine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Asenapine Sublingual Tablets, 5 mg recalled by SigmaPharm LaboratoriesAsenapine | SigmaPharm Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Saphris 10 mg (asenapine) sublingual tablets, count recalledSaphris | Forest Laboratories | Packaging Defects | Nationwide |