Major Pharmaceuticals recalls 12.5 mg Carvedilol Tablets due to NNCI impurity exceeding FDA limits. Affected units may pose health risks; contact for return instructions.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Major Pharmaceuticals is recalling 12.5 mg Carvedilol Tablets because they contain a harmful impurity (NNCI) at levels above FDA safety limits. This could potentially cause health issues if taken.
The tablets contain N-Nitroso Carvedilol Impurity-1 (NNCI) at levels above the FDA's safety limit of 4.0 ppm. This impurity could potentially cause health issues when taken as directed.
Prescription holders of the recalled Carvedilol Tablets are affected. Individuals with heart conditions requiring this medication are at higher risk.
Check for the product name 'Carvedilol Tablets USP, 12.5 mg, 100-tablets, (10x10) cartons' with NDC 0904-7307-61 and lot number T05693.
Verify the product's NDC code (0904-7307-61) and lot number (T05693) to confirm it is recalled.
The recall record states the impurity levels exceed FDA limits, so it is not safe to take as directed.
Check for NDC 0904-7307-61 and lot number T05693 on the packaging.
The recall record does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send Major Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0594-2025 — Major Pharmaceuticals Major Pharmaceuticals Hello, I own a Major Pharmaceuticals that is covered by recall D-0594-2025 from Major Pharmaceuticals. 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.
