Saphris Asenapine Tablets Recalled for Labeling Mixup
Forest Laboratories is recalling Saphris (asenapine) sublingual tablets because blister packs labeled as 10 mg actually contain 5 mg tablets.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (dose mixup) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Forest Laboratories, LLC is recalling 40,621 blister packs of Saphris (asenapine maleate) sublingual tablets. The recall involves lots W00733 and W00946 with an expiration date of April 2019. The product is distributed nationwide.
The recall was initiated due to a labeling mixup. The blister lidding foil and shell-pack are labeled as 10 mg, but the packages actually contain 5 mg tablets. This discrepancy could lead to patients receiving an incorrect dosage of the medication.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The product is a prescription-only medication manufactured by Catalent UK Swindon, Zydis Ltd, and distributed by Forest Pharmaceuticals, Inc.
The recalled product
- Product
- SAPHRIS (ASENAPINE MALEATE)
- Brand
- SAPHRIS
- Manufacturer
- Forest Laboratories, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 40,621
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 (2)
- Lots W00733 and W00946
- exp Apr 2019
Distribution
Distributed nationwide across the United States.
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