# FDA recall D-0041-2025

> **Direct Rx** · Class II · drug recall initiated 2024-08-09.

## Product

Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg,  Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles).

## Reason for recall

Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0041-2025
- **Recalling firm:** Direct Rx
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-08-09
- **Report date:** 2024-11-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dawsonville, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0041-2025

## Citation

> AI Analytics. FDA recall D-0041-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0041-2025. Source: US FDA. Licensed CC0.

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