Sulfamethoxazole and Trimethoprim Recall: Northwind Lot F118062503
Announced 2025-09-24 · FDA
Northwind Pharmaceuticals LLC recalled Sulfamethoxazole and Trimethoprim Tablets, USP 800 mg / 160 mg Double Strength repackaged from Amneal Pharmaceuticals and distributed nationwide in the United States. A foreign polyester coil used in packaging was detected with presence of a micro-organism; no micro-organism was detected on any tablets. The recall lists multiple lot numbers with expiration dates through 2027; corrective action is not specified.
| Brand | Northwind Pharmaceuticals LLC |
|---|---|
| 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 | 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. |
| Severity | moderate |
| Units affected | 96 |
| Distribution | Nationwide within the United States |
| Agency | FDA |
| Recall / campaign no. | Lot #: a) F118062503, Exp Date 05/31/2027, F118062507, Exp Date. 07/31/2027. b) F118062504, F118062505, Exp. Date 05/31/2027; F118062509, Exp. Date. 08/31/2027; F118062512, Exp. Date 04/30/2027. c) F118062506, Exp. Date 06/30/2027. d) F118062423, Exp. Date 01/31/2027; F118062501, Exp. Date 06/30/2027; F118062502, Exp. Date 04/30/2027; F118062508, Exp. Date 08/31/2027. |
WHAT YOU SHOULD DO
- Do not use recalled medication.
- Check your bottle's lot number against the recall list and return affected product to the pharmacy or discard per local guidelines.
- Contact your healthcare provider for guidance and request a replacement if needed.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.