# FDA recall D-0488-2025

> **Amneal Pharmaceuticals, LLC** · Class I · drug recall initiated 2025-06-02.

## Product

Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.

## Reason for recall

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0488-2025
- **Recalling firm:** Amneal Pharmaceuticals, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-06-02
- **Report date:** 2025-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bridgewater, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0488-2025

## Citation

> AI Analytics. FDA recall D-0488-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0488-2025. Source: US FDA. Licensed CC0.

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