# FDA recall D-0230-2022

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2021-10-25.

## Product

Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01

## Reason for recall

Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

## Distribution

Distributed to one distributor who may have further distribute the product nationwide.

## Key facts

- **Recall number:** D-0230-2022
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-10-25
- **Report date:** 2021-11-17
- **Termination date:** 2022-09-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0230-2022

## Citation

> AI Analytics. FDA recall D-0230-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0230-2022. Source: US FDA. Licensed CC0.

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