SigmaPharm Recalls Asenapine Tablets Due to Incorrect Flavoring Agent
SigmaPharm Laboratories LLC is recalling Asenapine Sublingual Tablets because they were manufactured with the incorrect flavoring agent.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a minor formulation error regarding flavoring.
Plain-English summary
SigmaPharm Laboratories LLC is recalling Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets. The recall involves 8,786 bottles distributed nationwide in the US. The specific lots affected are # 2012801, 2012901, 2013001 & Lot 2100501 (Exp AUG 2022) and 2100101 (Exp NOV 2022).
The recall was initiated because the product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of the required Art Black Cherry Flavor flavoring agent. This is classified as an FDA Class III recall, indicating a remote possibility of adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be returned to the pharmacy or distributor for disposal or replacement.
The recalled product
- Product
- ASENAPINE (ASENAPINE)
- Brand
- ASENAPINE
- Manufacturer
- SigmaPharm Laboratories LLC
- Category
- Drug — Antipsychotic
- Hazard
- Affected units
- 8,786
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lots # 2012801
- 2012901
- 2013001 & Lot 2100501
- Exp AUG 2022
- 2100101
- Exp NOV 2022
UPCs (6)
- 0342794016103
- 0342794017100
- 0342794017087
- 0342794016226
- 0342794016080
- 0342794017223
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by SigmaPharm Laboratories LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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