Reported Aug 27, 2025 · Ongoing
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · 341 Mason Rd · La Vergne, TN · 37086-3606
Is this the product you have?
- Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
- Lot codes and dates
Lot #: T05693Exp. Date 03/2026
- Amount recalled
- 26,628 cartons
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
This product could cause temporary or reversible health problems — stop using it.
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