# FDA recall D-0644-2024

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2024-08-06.

## Product

IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle,  b)NDC 55111-684-05 - 500 Tablets per bottle.

## Reason for recall

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0644-2024
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-08-06
- **Report date:** 2024-09-04

- **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-0644-2024

## Citation

> AI Analytics. FDA recall D-0644-2024. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0644-2024. Source: US FDA. Licensed CC0.

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