# FDA recall D-0068-2022

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class III · drug recall initiated 2021-10-12.

## Product

Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15

## Reason for recall

Failed Moisture Limits

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0068-2022
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-10-12
- **Report date:** 2021-11-03
- **Termination date:** 2023-08-31

- **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-0068-2022

## Citation

> AI Analytics. FDA recall D-0068-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0068-2022. Source: US FDA. Licensed CC0.

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