# FDA recall D-0011-2019

> **Jubilant Cadista Pharmaceuticals, Inc.** · Class II · drug recall initiated 2018-10-02.

## Product

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD  21801; NDC 59746-284-90.

## Reason for recall

Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.

## Distribution

Product was distributed Nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-0011-2019
- **Recalling firm:** Jubilant Cadista Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-10-02
- **Report date:** 2018-10-17
- **Termination date:** 2020-02-24

- **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-0011-2019

## Citation

> AI Analytics. FDA recall D-0011-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0011-2019. Source: US FDA. Licensed CC0.

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