Reported Jun 18, 2025 · Ongoing
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b)…
Amneal Pharmaceuticals, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Amneal Pharmaceuticals, LLC · 400 Crossing Blvd Fl 3 · Bridgewater, NJ · 08807-2863
Is this the product you have?
- Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle
- NDC
65162-271-10b) 500 Tablets per Bottle
- NDC65162-271-50
- Manufactured byAmneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA
- Distributed byAmneal Pharmaceuticals LLC, Bridgewater, NJ 08807
- Lot codes and dates
Lot #s: a) AM241019AM241020Exp. 06/30/2027 b) AM241019AExp 06/30/2027
- Amount recalled
- 6396 bottles
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Using this product could cause serious injury, illness or death — stop using it now.
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