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

Products covered by this recall
#Product as published
16-count bottles (NDC 51655-307-87)
210-count bottles (NDC 51655-307-53)
314-count bottles (NDC 51655-307-84)
420-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
1F118062503, Exp Date 05/31/2027, F118062507, Exp Date. 07/31/2027.
2F118062504, F118062505, Exp. Date 05/31/2027; F118062509, Exp. Date. 08/31/2027; F118062512, Exp. Date 04/30/2027.
3F118062506, Exp. Date 06/30/2027.
4F118062423, 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 7:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.