# FDA recall D-0033-2025

> **Denison Pharmaceuticals, LLC** · Class III · drug recall initiated 2024-09-25.

## Product

Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP  400mg),  packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155

## Reason for recall

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

## Distribution

Product was distributed to two accounts that may have distributed the product further to the Retail Level.

## Key facts

- **Recall number:** D-0033-2025
- **Recalling firm:** Denison Pharmaceuticals, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-09-25
- **Report date:** 2024-11-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lincoln, RI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0033-2025

## Citation

> AI Analytics. FDA recall D-0033-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0033-2025. Source: US FDA. Licensed CC0.

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