# FDA recall D-0096-2023

> **Jubilant Cadista Pharmaceuticals, Inc.** · Class III · drug recall initiated 2022-12-27.

## Product

Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06

## Reason for recall

Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0096-2023
- **Recalling firm:** Jubilant Cadista Pharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-12-27
- **Report date:** 2023-01-11
- **Termination date:** 2023-12-05

- **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-0096-2023

## Citation

> AI Analytics. FDA recall D-0096-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0096-2023. Source: US FDA. Licensed CC0.

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