# FDA recall D-0471-2025

> **Aurobindo Pharma USA Inc** · Class II · drug recall initiated 2025-05-22.

## Product

Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10

## Reason for recall

cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).

## Distribution

USA Nationwide.

## Key facts

- **Recall number:** D-0471-2025
- **Recalling firm:** Aurobindo Pharma USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-05-22
- **Report date:** 2025-06-25

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0471-2025

## Citation

> AI Analytics. FDA recall D-0471-2025. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0471-2025. Source: US FDA. Licensed CC0.

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