# FDA recall D-0729-2021

> **Spirit Pharmaceuticals** · Class II · drug recall initiated 2021-06-16.

## Product

Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10

## Reason for recall

cGMP deviations: Discolored acetaminophen

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0729-2021
- **Recalling firm:** Spirit Pharmaceuticals
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-06-16
- **Report date:** 2021-08-25
- **Termination date:** 2022-09-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ronkonkoma, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0729-2021

## Citation

> AI Analytics. FDA recall D-0729-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0729-2021. Source: US FDA. Licensed CC0.

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