# FDA recall D-0523-2026

> **Acella Pharmaceuticals, LLC** · Class II · drug recall initiated 2026-04-20.

## Product

NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada  NDC 42192-619-16

## Reason for recall

Chemical contamination; presence of lead and lithium above specification

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0523-2026
- **Recalling firm:** Acella Pharmaceuticals, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-04-20
- **Report date:** 2026-05-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0523-2026

## Citation

> AI Analytics. FDA recall D-0523-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0523-2026. Source: US FDA. Licensed CC0.

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