# FDA recall D-0565-2023

> **Family Dollar Stores, Llc.** · Class II · drug recall initiated 2023-03-31.

## Product

Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever,  36 Caplets bottles

## Reason for recall

CGMP deviation: product outside labeled storage temperature requirements.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0565-2023
- **Recalling firm:** Family Dollar Stores, Llc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-03-31
- **Report date:** 2023-05-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chesapeake, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0565-2023

## Citation

> AI Analytics. FDA recall D-0565-2023. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0565-2023. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
