# FDA recall D-1058-2020

> **Jubilant Cadista Pharmaceuticals, Inc.** · Class II · drug recall initiated 2020-03-11.

## Product

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90

## Reason for recall

CGMP Deviations: Presence of dark brown discoloration on edges of tablets

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-1058-2020
- **Recalling firm:** Jubilant Cadista Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-03-11
- **Report date:** 2020-03-25
- **Termination date:** 2020-06-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salisbury, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1058-2020

## Citation

> AI Analytics. FDA recall D-1058-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1058-2020. Source: US FDA. Licensed CC0.

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