# FDA recall D-0852-2022

> **Torrent Pharma Inc** · Class II · drug recall initiated 2022-04-11.

## Product

Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90.

## Reason for recall

CGMP deviations: tablets cracking

## Distribution

Nationwide in the U.S.A

## Key facts

- **Recall number:** D-0852-2022
- **Recalling firm:** Torrent Pharma Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-04-11
- **Report date:** 2022-05-11
- **Termination date:** 2023-07-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Levittown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0852-2022

## Citation

> AI Analytics. FDA recall D-0852-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0852-2022. Source: US FDA. Licensed CC0.

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