# FDA recall D-0654-2025

> **Northwind Pharmaceuticals LLC** · Class II · drug recall initiated 2025-08-20.

## Product

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203.

## Reason for recall

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0654-2025
- **Recalling firm:** Northwind Pharmaceuticals LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-08-20
- **Report date:** 2025-09-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0654-2025

## Citation

> AI Analytics. FDA recall D-0654-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0654-2025. Source: US FDA. Licensed CC0.

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