# FDA recall D-0075-2021

> **Zydus Pharmaceuticals (USA) Inc** · Class II · drug recall initiated 2020-10-27.

## Product

Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-772-77

## Reason for recall

Failed Dissolution Specification

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0075-2021
- **Recalling firm:** Zydus Pharmaceuticals (USA) Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-10-27
- **Report date:** 2020-11-11
- **Termination date:** 2022-12-20

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0075-2021

## Citation

> AI Analytics. FDA recall D-0075-2021. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0075-2021. Source: US FDA. Licensed CC0.

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