Sulfamethoxazole and Trimethoprim Tablets — Class II drug recall D-0654-2025
Ongoing recall by Northwind Pharmaceuticals LLC, reported 2025-09-24, distributed nationwide. Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manu
| Recall number | D-0654-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Northwind Pharmaceuticals LLC, Indianapolis, IN, United States |
| Recall initiated | 2025-08-20 |
| Classified | 2025-09-17 |
| Reported by FDA | 2025-09-24 |
| Distributed | Nationwide (US) |
| NDC | 51655-0307, 51655-0307-20, 51655-0307-29, 51655-0307-53, 51655-0307-84, 51655-0307-87 |
| Expiration dates | 2027-01-31, 2027-04-30, 2027-05-31, 2027-06-30, 2027-07-31, 2027-08-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0654-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.