Amneal Pharmaceuticals recalls 400mg/80mg sulfamethoxazole and trimethoprim tablets with black spots due to microbial contamination. Stop using affected lots immediately.
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Amneal Pharmaceuticals is recalling certain sulfamethoxazole and trimethoprim tablets that may have black spots from microbial contamination. This could cause illness if taken, so affected users should stop using the product immediately.
Microbial contamination in non-sterile products can lead to infections. Black spots on the tablets indicate possible contamination that could cause illness if taken.
Prescription users of the recalled tablets, particularly those with compromised immune systems or ongoing infections, are most at risk from potential illness.
Check for black spots on the tablets. Affected lots have NDC numbers 65162-271-10 (100 tablets) or 65162-271-50 (500 tablets), manufactured in India with specific lot numbers.
Discard any tablets with black spots as they may contain harmful microbes.
Microbial contamination in non-sterile products may cause illness if taken, indicated by black spots on the tablets.
The recalled tablets have NDC numbers 65162-271-10 (100 tablets) or 65162-271-50 (500 tablets).
Look for black spots on the tablets. Affected lots have specific NDC numbers and were manufactured in India with lot numbers AM241019 or AM241019A.
We’ve drafted a message you can send Amneal to request your refund or repair — edit it as you like.
Subject: Recall D-0488-2025 — Amneal Amneal Hello, I own a Amneal that is covered by recall D-0488-2025 from Amneal. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
