# FDA recall D-0880-2017

> **Forest Laboratories, LLC** · Class II · drug recall initiated 2017-05-18.

## 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

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0880-2017
- **Recalling firm:** Forest Laboratories, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-05-18
- **Report date:** 2017-06-07
- **Termination date:** 2018-11-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jersey City, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0880-2017

## Citation

> AI Analytics. FDA recall D-0880-2017. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0880-2017. Source: US FDA. Licensed CC0.

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