Class IIOngoing

Sulfamethoxazole and Trimethoprim Tablets recall

FDA recall D-0615-2025 · initiated Aug 18, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Details

Product: Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Recalling company: Amneal
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Distributed Nationwide in the USA
Initiated: Aug 18, 2025
FDA report date: Sep 10, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0615-2025 ↗

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