SigmaPharm Recalls Asenapine Tablets Due to Incorrect Flavoring Agent
SigmaPharm Laboratories is recalling Asenapine sublingual tablets because they were manufactured with the wrong 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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor labeling or formulation errors.
Plain-English summary
SigmaPharm Laboratories LLC is recalling Asenapine sublingual tablets, 5 mg, prescription only, 60 tablets per bottle. The recall involves 6,266 bottles distributed nationwide in the US. The affected lots are #2012501, #2012601, #2012701, and #2100701, all with an expiration date of August 2022.
The recall was initiated because the product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of the intended Art Black Cherry Flavor flavoring agent. This is a Class III recall, indicating that use of or exposure to the violative product is not likely to cause 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 description, it should be returned to the pharmacy or distributor for disposal or credit.
The recalled product
- Product
- ASENAPINE (ASENAPINE)
- Brand
- ASENAPINE
- Manufacturer
- SigmaPharm Laboratories LLC
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 6,266
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 (5)
- Lots # 2012501
- 2012601
- 2012701
- & 2100701
- Exp. AUG 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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