Saphris 10 mg — Class II drug recall D-0880-2017
Terminated recall by Forest Laboratories, LLC, reported 2017-06-07, distributed nationwide. Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg
| Recall number | D-0880-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Forest Laboratories, LLC, Jersey City, NJ, United States |
| Recall initiated | 2017-05-18 |
| Classified | 2017-05-31 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2018-11-15 |
| Distributed | Nationwide (US) |
| Quantity | 40,621 blister |
| Reason classes | labeling |
| NDC | 00456-2402, 00456-2402-06, 00456-2402-10, 00456-2402-11, 00456-2402-60, 00456-2402-63, 00456-2405, 00456-2405-06, 00456-2405-10, 00456-2405-11, 00456-2405-60, 00456-2405-63, 00456-2410, 00456-2410-06, 00456-2410-10, 00456-2410-11, 00456-2410-60, 00456-2410-63 |
| Lot numbers | W00733, W00946 |
| Expiration dates | 2019-04-20 |
Product
Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindon, Zydis Ltd, Blagrove, Swindon, Wilshire SN5 BRU, UK Distributed by Forest Pharmaceuticals, Inc. subsidiary of Forest Laboratories, LLC, Cincinnati OH 45209 USA --- NDC 0456-2410-60; Shellpack containing 1 blister card --- NDC 0456-2410-06
Reason for recall
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0880-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.