# FDA recall D-0810-2016

> **Purdue Pharma L.P.** · Class III · drug recall initiated 2016-03-31.

## Product

Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only.  Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.

## Reason for recall

Failed Dissolution Specifications

## Distribution

U.S. Including: FL, LA, MI, MS, NC, NJ, OH and SC.

## Key facts

- **Recall number:** D-0810-2016
- **Recalling firm:** Purdue Pharma L.P.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-03-31
- **Report date:** 2016-04-13
- **Termination date:** 2017-04-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Stamford, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0810-2016

## Citation

> AI Analytics. FDA recall D-0810-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0810-2016. Source: US FDA. Licensed CC0.

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