# FDA recall D-0530-2023

> **Hetero USA Inc** · Class II · drug recall initiated 2023-03-14.

## Product

Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10

## Reason for recall

CGMP Deviations: Discoloration

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0530-2023
- **Recalling firm:** Hetero USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-03-14
- **Report date:** 2023-04-19

- **Voluntary/Mandated:** N/A
- **Location:** Piscataway, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0530-2023

## Citation

> AI Analytics. FDA recall D-0530-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0530-2023. Source: US FDA. Licensed CC0.

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