# FDA recall D-0853-2022

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2022-04-15.

## Product

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78.

## Reason for recall

Failed Dissolution Specifications

## Distribution

OH

## Key facts

- **Recall number:** D-0853-2022
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-04-15
- **Report date:** 2022-05-11
- **Termination date:** 2023-11-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0853-2022

## Citation

> AI Analytics. FDA recall D-0853-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0853-2022. Source: US FDA. Licensed CC0.

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