CLASS II Drug recall · Reported 7 Jun 2017 · FDA Enforcement Report
Saphris 10 mg (asenapine) sublingual tablets, count recalled
Forest Laboratories is recalling Saphris 10 mg (asenapine) sublingual tablets, count, distributed nationwide in the US. The recall was initiated on 18 May 2017 and the FDA has classified it as Class II.
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-0880-2017
- FDA event ID
- 77315
- Recalling firm
- Forest Laboratories, Jersey City, NJ
- Brand
- Saphris
- Manufacturer
- Allergan, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 May 2017
- FDA classified
- 31 May 2017
- Reported
- 7 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 18 May 2017 | Recall initiated by company | |
| 31 May 2017 | Classified by FDA | +13 days |
| 7 Jun 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
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
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Which lots are affected?
Lots W00733 and W00946, exp Apr 2019
Where was it sold?
Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Asenapine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Asenapine Sublingual Tablets, 10 mg recalled by SigmaPharm LaboratoriesAsenapine | SigmaPharm Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS III | Asenapine Sublingual Tablets, 5 mg recalled by SigmaPharm LaboratoriesAsenapine | SigmaPharm Laboratories | Packaging Defects | Nationwide |