# FDA recall D-0693-2017

> **Amneal Pharmaceuticals LLC** · Class II · drug recall initiated 2016-12-12.

## Product

Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide within the US and PR

## Key facts

- **Recall number:** D-0693-2017
- **Recalling firm:** Amneal Pharmaceuticals LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-12-12
- **Report date:** 2017-05-10
- **Termination date:** 2019-04-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Glasgow, KY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0693-2017

## Citation

> AI Analytics. FDA recall D-0693-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0693-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*