# FDA recall D-0627-2024

> **Granules Consumer Health Inc.** · Class III · drug recall initiated 2024-07-18.

## Product

Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India

## Reason for recall

Label mix-up: Carton incorrectly labeled.

## Distribution

Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.

## Key facts

- **Recall number:** D-0627-2024
- **Recalling firm:** Granules Consumer Health Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-07-18
- **Report date:** 2024-08-14
- **Termination date:** 2026-02-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0627-2024

## Citation

> AI Analytics. FDA recall D-0627-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0627-2024. Source: US FDA. Licensed CC0.

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