Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Sulfamethoxazole and Trimethoprim Tablets Recalled by Amneal Pharmaceuticals, LLC Due to Microbial contamination of non-sterile products: tablets may exhibit...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Amneal Pharmaceuticals, LLC directly.
Affected Products
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Quantity: 6396 bottles
Why Was This Recalled?
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Amneal Pharmaceuticals, LLC
Amneal Pharmaceuticals, LLC has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report