Drug recall
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles…
FDA recall event 97544 · Class II · Northwind Pharmaceuticals LLC
Key facts
| Event ID | 97544 |
|---|---|
| Recall numbers | D-0654-2025 |
| Recalling firm | Northwind Pharmaceuticals LLC |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| 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… |
| Initiation date | Aug 20, 2025 |
| Report date | Sep 24, 2025 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 1831143 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: