# FDA recall D-0145-2020

> **Jubilant Cadista Pharmaceuticals, Inc.** · Class II · drug recall initiated 2019-09-04.

## Product

Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 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

CGMP Deviation: Presence of dark brown discoloration on edges of tablets.

## Distribution

Product was distributed to MS, OH, RI, TN and Puerto Rico to distributors and wholesalers who may have further distributed the product to the retail level.

## Key facts

- **Recall number:** D-0145-2020
- **Recalling firm:** Jubilant Cadista Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-09-04
- **Report date:** 2019-10-23
- **Termination date:** 2020-02-12

- **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-0145-2020

## Citation

> AI Analytics. FDA recall D-0145-2020. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-0145-2020. Source: US FDA. Licensed CC0.

---

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