# FDA recall D-1066-2019

> **Ascend Laboratories LLC** · Class II · drug recall initiated 2019-02-22.

## Product

Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ  07054, NDC 67877-450-05.

## Reason for recall

Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.

## Distribution

Nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-1066-2019
- **Recalling firm:** Ascend Laboratories LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-02-22
- **Report date:** 2019-03-13
- **Termination date:** 2020-03-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1066-2019

## Citation

> AI Analytics. FDA recall D-1066-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1066-2019. Source: US FDA. Licensed CC0.

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