Reported Sep 24, 2025 · Ongoing
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC…
Northwind Pharmaceuticals LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Northwind Pharmaceuticals LLC · 4838 Fletcher Ave Ste 1000 · Indianapolis, IN · 46203-1642
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | 6-count bottles (NDC 51655-307-87) |
| 2 | 10-count bottles (NDC 51655-307-53) |
| 3 | 14-count bottles (NDC 51655-307-84) |
| 4 | 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203. |
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 F118062503, Exp Date 05/31/2027, F118062507, Exp Date. 07/31/2027. 2 F118062504, F118062505, Exp. Date 05/31/2027; F118062509, Exp. Date. 08/31/2027; F118062512, Exp. Date 04/30/2027. 3 F118062506, Exp. Date 06/30/2027. 4 F118062423, Exp. Date 01/31/2027; F118062501, Exp. Date 06/30/2027; F118062502, Exp. Date 04/30/2027; F118062508, Exp. Date 08/31/2027. - Amount recalled
- a) 96 bottles, b) 627 bottles, c) 428 bottles, d) 1144 bottles
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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