Northwind Pharmaceuticals LLC: Drug Recall
Recall #D-0654-2025 · 08/20/2025
Class II: Risk
Recall Details
- Recall Number
- D-0654-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Northwind Pharmaceuticals LLC
- Status
- Ongoing
- Date Initiated
- 08/20/2025
- Location
- Indianapolis, IN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 96 bottles, b) 627 bottles, c) 428 bottles, d) 1144 bottles
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.
Product Description
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.
Distribution Pattern
Nationwide within the United States
Other Recalls by Northwind Pharmaceuticals LLC
- Class II: Risk 03/16/2023
- Class II: Risk 03/16/2023
- Class II: Risk 03/16/2023
- Class II: Risk 03/16/2023
- Class II: Risk 03/16/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.