# FDA recall D-0545-2024

> **Winder Laboratories, LLC** · Class II · drug recall initiated 2024-05-28.

## Product

Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10,

## Reason for recall

Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0545-2024
- **Recalling firm:** Winder Laboratories, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2024-05-28
- **Report date:** 2024-06-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0545-2024

## Citation

> AI Analytics. FDA recall D-0545-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0545-2024. Source: US FDA. Licensed CC0.

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