United StatesAmlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30‑count bottle (NDC 67877‑501‑30), Lot 24123460, expires October 31, 2027, manufactured by Alkem Laboratories Ltd. and distributed by Ascend Laboratories, LLC, are affected. They were recalled because olmesartan medoxomil failed dissolution specifications and had content below specifications; the recall is ongoing nationwide (15,696 bottles).
What's being recalled
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.
Recalling firm: Ascend Laboratories, LLC, Bedminster, NJ, United States.
How to identify it
Lot: 24123460, Expires: October 31, 2027.
The hazard
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S.A. Nationwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)